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Journal of Medicine and Pharmacy","Tạp chí Y Dược học Cần Thơ",{"EN":487,"VI":488},"\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">04\u002F10\u002F2015 Ministry of Information and Communications allowed Can Tho journal of medicine and pharmacy to operate (102 \u002FGP-BTTTT)\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">07\u002F16\u002F2015 Can Tho journal of medicine and pharmacy is internationally recognized: ISSN 2354-1210\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">In 2016, The journal has been included in the list of medical science journals by The State Council for professorship which is awarded a work score of 0-0.5 points for a published article.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Can Tho Journal of Medicine and Pharmacy welcome original works that haven’t been submitted or published in other medical journals. Posts must contain content related to one of the journal’s categories.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">The content published\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">The journal is divided into 3 categories:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Scientific research article: are valuable scientific works, which have been researched and accepted.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Overview of medicine, biology and pharmacy: serving the objective of continuing training in the fields of medicine, biology and pharmacy; to systematize classical and modern knowledge.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Update information on new knowledge about medicine, biology, pharmacy in the country and in the world.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Scope\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Publication and introduction of scientific research in the fields:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">+ Medicine (internal medicine, surgery, pediatrics, obstetrics and gynecology, odonto-stomatology, laboratory, oncology, traditional medicine, nursing).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">+ Biology (genetics, biotechnology).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">+ Pharmacology (pharmaceutics, drug quality analysis-control, synthetic pharmaceutical chemistry, biochemistry, pharmacognosy, botany, clinical pharmacy).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- To enhance the quality of undergraduate, postgraduate education, scientifically researching and meet the necessary treatment in hospital.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Introducing the updated domestic and oversea information about science technology to promote scientific research and exchanging technology in local, other universities.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">- Exchanging pharmaceutical and medical information for social health developing in the Mekong Delta and Vietnam.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">The object\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Postgraduate students, student of Can Tho University of Medicine and Pharmacy, scientists from schools, research institutes, hospitals, health centers, pharmaceutical companies of the Mekong Delta; other provinces and regions in Vietnam and other country.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Address\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Headquarters of Can Tho Journal of Medicine and Pharmacy, located Scientific Research and International Cooperation Office: 179 Nguyen Van Cu Street, An Khanh Ward, Ninh Kieu District, Can Tho City, Vietnam.\u003C\u002Fspan>\u003C\u002Fp>","\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Ngày 16\u002F7\u002F2015, Tạp chí Y Dược học Cần Thơ được cấp chỉ số quốc tế: ISSN 2354-1210.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Từ tháng 4\u002F2016, Tạp chí đã được Hội đồng Giáo sư ngành Y đưa vào danh sách các tạp chí khoa học Y học được tính điểm công trình 0-0,5 điểm cho một bài báo đăng.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Năm 2020 Tạp chí Y Dược học Cần Thơ đã được phê duyệt vào danh mục của các Hội đồng Giáo sư ngành Dược học được tính điểm công trình 0-0,5 điểm cho một bài báo đăng.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tạp chí Y Dược học Cần Thơ ra 12 số\u002Fnăm, 180-200 trang\u002Fsố.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Từ tháng 12\u002F2022 Tạp chí Y Dược học Cần Thơ là thành viên của hệ thống Crossref và từ tháng 01\u002F2023 tạp chí thực hiện bình duyệt online kín 2 chiều nhằm tăng tính minh bạch, tin cậy của các công trình nghiên cứu khoa học và đảm bảo tốt nhất chất lượng khoa học của bài viết.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tôn chỉ, mục đích và phạm vi của tạp chí\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tôn chỉ và mục đích hoạt động của tạp chí: xuất bản nhằm mục đích phổ biến kết quả từ các đề tài nghiên cứu khoa học; giao lưu trao đổi khoa học, chia sẻ kinh nghiệm, học tập, đồng thời cập nhật thông tin khoa học mới trong các lĩnh vực y, sinh, dược học trong và ngoài nước.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Phạm vi của tạp chí: Tạp chí xuất bản được chia thành 3 chuyên mục: (i) Bài báo nghiên cứu khoa học là kết quả công trình nghiên cứu khoa học có giá trị đã được triển khai nghiên cứu, (ii) Bài tổng quan y, sinh, dược học: phục vụ mục tiêu đào tạo liên tục trong lĩnh vực y, sinh, dược học; nhằm hệ thống hóa những kiến thức kinh điển và hiện đại; (iii) Thông tin cập nhật kiến thức mới về y, sinh, dược học trong nước và trên thế giới.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Chính sách truy cập mở\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tạp chí Y Dược học Cần Thơ áp dụng chính sách truy cập mở đối với các bài báo đã xuất bản đến với độc giả, nhằm mở rộng cơ hội tiếp cận các kết quả nghiên cứu chất lượng cao và tăng cường trao đổi kiến thức. Tạp chí đăng tải trực tuyến (miễn phí) toàn văn các bài báo được công bố trên website của Tạp chí (https:\u002F\u002Ftapchi.ctump.edu.vn).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Đạo đức xuất bản\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tạp chí Y Dược học Cần Thơ cam kết tuân thủ đạo đức xuất bản phù hợp với các hướng dẫn và tiêu chuẩn của the Committee on Publication Ethics (COPE), tuân thủ các nguyên tắc của COPE’s Core Practices, Best Practices Guidelines for Journal Editors và Guidelines on Good Publication Practices.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Bản thảo bài báo chỉ được chấp nhận khi được tác giả chịu trách nhiệm chính cam kết các nội dung sau: Các nội dung của bản thảo chưa được đăng tải toàn bộ hoặc một phần ở các tạp chí khác; Tất cả các tác giả đều có đóng góp một cách đáng kể vào quá trình nghiên cứu hoặc chuẩn bị bản thảo và cùng chịu trách nhiệm về các nội dung của bản thảo; Tuân thủ các biện pháp đảm bảo đạo đức nghiên cứu (ví dụ thỏa thuận đồng ý tham gia nghiên cứu).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Cam kết bảo mật\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tạp chí cam kết thực hiện và tuân thủ các quy định của luật và các văn bản hướng dẫn liên quan đến bảo mật thông tin cá nhân trên không gian mạng. Các thông tin mà người dùng (tác giả, độc giả, biên tập viên, người phản biện) nhập vào các biểu mẫu trên Hệ thống Quản lý xuất bản trực tuyến của tạp chí chỉ được sử dụng vào các mục đích đã được tuyên bố rõ ràng và sẽ không được cung cấp cho bất kỳ bên thứ ba nào khác, hay dùng vào bất kỳ mục đích nào khác.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Phí gửi bài\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Lệ phí gửi đăng bài: 1.000.000đ\u002Fbài báo\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Lệ phí gửi đăng nhanh: 1.500.000đ\u002Fbài báo\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Đối với tác giả là cán bộ viên chức thuộc Trường Đại học Y Dược Cần Thơ thì được hỗ trợ 50% lệ phí gửi đăng bài.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Đối với sinh viên thực hiện đề tài nghiên cứu khoa học cấp trường được hỗ trợ 100% lệ phí đăng bài ( Tác giả gửi đính kèm “ Quyết định về việc giao tổ chức thực hiện đề tài nghiên cứu khoa học cấp Trường của sinh viên”).\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Hình thức nộp lệ phí:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">1. Tiền mặt:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Nộp trực tiếp tại Phòng Tài chính - Kế toán, Trường Đại học Y Dược Cần Thơ, số 179 Nguyễn Văn Cừ, P. An Khánh, Q. Ninh Kiều, thành phố Cần Thơ.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">2. Chuyển khoản:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tên Tài khoản: Trường ĐHYD Cần Thơ, Số TK: 0111000115668, tại ngân hàng Vietcombank chi nhánh Cần Thơ.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Thời gian: Áp dụng từ ngày 01\u002F02\u002F2023.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">* Phí gửi bài không được hoàn trả khi bài viết bị từ chối hoặc tác giả xin rút bài viết.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Quy trình phản biện bài báo\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tạp chí Y Dược học Cần Thơ thực hiện quy trình phản biện kín hai chiều nghiêm ngặt. Danh tính của những người phản biện không được tiết lộ cho các tác giả và ngược lại. Quy trình thẩm định bài báo đăng gồm các bước sau:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tiếp nhận bản thảo\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Tác giả liên hệ gửi bản thảo đến Tạp chí qua hệ thống trực tuyến tại website: https:\u002F\u002Ftapchi.ctump.edu.vn. Hướng dẫn về cách đăng ký, gửi bài và chuẩn bị bản thảo được cung cấp trên website của Tạp chí.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Sàng lọc sơ bộ\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Sau khi Tòa soạn nhận được bài báo của tác giả, Ban Thư ký sẽ tiến hành kiểm tra sơ bộ bài báo (các yêu cầu về nội dung và hình thức). Những bài báo không đúng quy cách hoặc có nội dung không phù hợp hoặc vi phạm bản quyền sẽ bị từ chối (Ban Thư ký thông báo phản hồi đến tác giả trong vòng 1 tuần). Những bài báo đủ điều kiện, được Ban Thư ký tòa soạn chuyển đến Ban Biên tập có cùng chuyên môn với nội dung bài báo để đề xuất người phản biện. Thời gian kể từ khi Ban Biên tập nhận bài báo đến khi đề xuất người phản biện bài báo chậm nhất là 5 ngày.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Vòng phản biện\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">1. Ban Thư ký gửi bài và yêu cầu phản biện đến 02 phản biện độc lập.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">2. Các phản biện gởi nhận xét cho Ban Thư ký. Thời gian từ khi gửi bài cho phản biện đến khi nhận ý kiến của phản biện tối đa là 20 ngày.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Xử ký kết quả phản biện\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">1. Nếu ý kiến đồng ý cho đăng và không cần chỉnh sửa, Ban Thư ký tiếp tục đăng bài theo qui trình.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">2. Nếu ý kiến đồng ý đăng và cần chỉnh sửa, Ban Thư ký sẽ thông tin đến tác giả chỉnh sửa theo yêu cầu của người phản biện. Thời gian chỉnh sửa và gửi lại kéo dài không quá 2 tuần, từ khi tác giả bài báo nhận được thông tin (Quá trình này có thể lặp lại tối đa 2 lần\u002F1 bài báo). Khi có sự thống nhất, đồng ý của người phản biện; bài báo được tiếp tục đăng theo qui trình.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">3. Những bài báo có chất lượng không đạt yêu cầu, cả 2 phản biện không đồng ý cho đăng sẽ bị Tòa soạn từ chối đăng.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">Xuất bản\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">1. Ban Thư ký tổng hợp các bản thảo đã được tác giả hoàn thiện sau thẩm định trình Ban Biên tập xem xét, Tổng Biên tập phê duyệt, quyết định bài đăng theo các tiêu chí: sự phù hợp nội dung với tôn chỉ và mục đích, thể loại bài viết (ưu tiên các bài có bài có nghiên cứu chuyên sâu, hàm lượng khoa học cao), đóng góp mới bài báo, bài báo được ưu tiên đăng trong số gần nhất của Tạp chí theo thứ tự: tính thời sự, chất lượng bài báo và thời gian gửi bài.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">2. Ban Biên tập và Ban Thư ký biên tập bản thảo, chế bản, đọc rà soát lỗi. Thời gian hoàn thành từ 10-15 ngày.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">3. Ban Thư ký có trách nhiệm thông báo cho tác giả bài báo (bằng e-mail) về tình hình phê duyệt bài báo, thời gian, số kỳ, tập xuất bản bài báo theo qui định.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>\u003Cp>\u003Cspan style=\"color: rgb(0, 0, 0);\">4. Danh sách bài báo theo số Tạp chí được in ấn và phát hành trong năm định kỳ được công bố chính thức trên website: https:\u002F\u002Ftapchi.ctump.edu.vn\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cbr>\u003C\u002Fp>",{"VOID":490},"wcQ1uqwAAAAJ","2023-05-30T08:17:21.868+00:00",[],[494],{"id":495,"createTime":28,"updateTime":28,"relativeEntities":496,"slug":28,"properties":497,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":507,"parentIds":508,"statistic":28},"6413896b-eca9-442b-a73f-182a58a0ce40",[],{"title":498,"address":501,"country":504,"abbreviation":505},{"EN":499,"VI":500},"Can Tho University of Medicine and Pharmacy","Trường Đại học Y Dược Cần Thơ",{"EN":502,"VI":503},"No 179, Nguyen Van Cu street, An Khanh ward, Ninh Kieu district, Can Tho city, Vietnam","Số 179, đường Nguyễn Văn Cừ, phường An Khánh, quận Ninh Kiều, thành phố Cần Thơ, Việt Nam",{"VOID":15},{"VOID":506},"ctump","http:\u002F\u002Fwww.ctump.edu.vn\u002F",[],[],"https:\u002F\u002Ftapchi.ctump.edu.vn\u002Findex.php\u002Fctump",{"impactFactor":32,"impactFactorByYear":512,"i10Index":32,"i10IndexLast5Year":32,"totalPublication":514,"totalPublicationByYear":515,"totalCitation":520,"totalCitationByYear":521,"totalCitationPerPublication":108,"totalCitationPerPublicationByYear":523,"hindexLast5Year":45,"hindex":45},{"2022":513,"2023":111,"2024":106},0.01,1556,{"2020":47,"2021":516,"2022":517,"2023":518,"2024":519,"2025":122},57,306,801,358,161,{"2021":146,"2022":280,"2023":522},99,{"2021":524,"2022":318,"2023":104},0.23,{"impactFactor":28,"impactFactorByYear":28,"i10Index":123,"i10IndexLast5Year":123,"totalPublication":526,"totalPublicationByYear":527,"totalCitation":526,"totalCitationByYear":528,"totalCitationPerPublication":40,"totalCitationPerPublicationByYear":531,"hindexLast5Year":49,"hindex":49},476,{"0":205,"2019":123,"2021":139,"2022":459,"2023":451,"2024":357,"2025":49,"2026":48},{"2021":42,"2022":123,"2023":161,"2024":529,"2025":360,"2026":530},136,83,{"2021":105,"2022":513,"2023":532,"2024":127,"2025":533,"2026":534},0.62,25.43,13.83,{"id":536,"createTime":537,"updateTime":382,"relativeEntities":538,"slug":539,"properties":540,"entityType":25,"verifyStatus":26,"verifyTime":28,"verifyNote":28,"languages":552,"translateLanguages":28,"viewCount":133,"subjectFields":553,"manageAffiliations":554,"indexDatabases":555,"url":556,"thumbnailPath":557,"statistic":558,"gsStatistic":594,"type":55,"analyzePriority":28},"6984a56a-db70-403b-9cc4-4013e1ceaffa","2023-05-09T06:47:40.346+00:00",[],"T%E1%BA%A1p%20ch%C3%AD%20Nghi%C3%AAn%20c%E1%BB%A9u%20n%C6%B0%E1%BB%9Bc%20ngo%C3%A0i",{"country":541,"issn":542,"title":544,"introduce":547,"gsId":550},{"VOID":15},{"VOID":543},"25252445",{"EN":545,"VI":546},"VNU Journal of Foreign Studies","Tạp chí Nghiên cứu nước ngoài",{"EN":548,"VI":549},"{\"ops\":[{\"insert\":\"\\n\\nThe \\n\"},{\"attributes\":{\"italic\":true},\"insert\":\"VNU Journal of Science\"},{\"insert\":\"\\n was established in 1985 for the publication of national and international research papers in all fields of natural sciences and technology, social sciences and humanities. 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Considering the difficulties in establishing full-scale IVIVC and limited in vivo pharmacokinetics data in the early stage of formulation development, we have selected BCS III drug metformin as a model drug to demonstrate a novel approach for the selection of BE formulations. Firstly, dissolution tests in both standard and biorelevant media were performed followed by identification of the most similar formulation WM to the reference product (GXR) based on principal component analysis (PCA) of the dissolution data. Then, we developed an IVIVC model using the reported GXR pharmacokinetics profiles via a convolution-based approach. Based on our established IVIVC and in vitro dissolution profiles of generic metformin ER products, we were able to predict their in vivo pharmacokinetic profiles and quantitatively compare the differences in AUC and Cmax to ensure the correct selection of BE product. Finally, the selection of WM as the BE formulation of GXR was confirmed with a pilot BE study in healthy volunteers under fasting state. Moreover, the in vivo data from the fed state study were further integrated into our IVIVC model to identify FeSSIF-V2 as the biorelevant media for WM. Our novel integrative approach of PCA with a convolution-based IVIVC was successfully adopted for the screening of the BE metformin ER formulation and such an approach could be further utilized for the effective selection of BE formulation for other drugs\u002Fformulations with complex in vivo absorption processes.",{"EN":993},"Screening of Bioequivalent Extended-Release Formulations for Metformin by Principal Component Analysis and Convolution-Based IVIVC Approach",{"VOID":995},"Center for Drug Evaluation and Research. Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs - General Considerations (DRAFT). US Food and Drug Administration; 2014.\nCenter for Drug Evaluation and Research. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro\u002Fin vivo correlations. US Food and Drug Administration; 1997.\nLe Guellec S, Ehrmann S, Vecellio L. In vitro - in vivo correlation of intranasal drug deposition. Adv Drug Deliv Rev. 2020. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.addr.2020.09.002.\nJacob S, Nair AB. An updated overview with simple and practical approach for developing in vitro-in vivo correlation. Drug Dev Res. 2018;79(3):97–110. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fddr.21427.\nKazi M, Al Amri R, Alanazi FK, Hussain MD. In vitro methods for in vitro-in vivo correlation (IVIVC) for poorly water soluble drugs: lipid based formulation perspective. Curr Drug Deliv. 2018;15(7):918–29. https:\u002F\u002Fdoi.org\u002F10.2174\u002F1567201815666180116090910.\nChoi SM, Kang CY, Lee BJ, Park JB. In vitro-in vivo correlation using in silico modeling of physiological properties, metabolites, and intestinal metabolism. Curr Drug Metab. 2017;18(11):973–82. https:\u002F\u002Fdoi.org\u002F10.2174\u002F1389200218666171031124347.\nShen J, Burgess DJ. In vitro-in vivo correlation for complex non-oral drug products: where do we stand? J Control Release. 2015;219:644–51. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jconrel.2015.09.052.\nKollipara S, Gandhi RK. Pharmacokinetic aspects and in vitro-in vivo correlation potential for lipid-based formulations. Acta Pharm Sin B. 2014;4(5):333–49. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.apsb.2014.09.001.\nLin Z, Zhou D, Hoag S, Qiu Y. Influence of drug properties and formulation on in vitro drug release and biowaiver regulation of oral extended release dosage forms. AAPS J. 2016;18(2):333–45. https:\u002F\u002Fdoi.org\u002F10.1208\u002Fs12248-015-9861-2.\nGiuliani A. The application of principal component analysis to drug discovery and biomedical data. Drug Discov Today. 2017;22(7):1069–76. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.drudis.2017.01.005.\nJolliffe IT, Cadima J. Principal component analysis: a review and recent developments. Philos Trans A Math Phys Eng Sci. 2016;374(2065):20150202. https:\u002F\u002Fdoi.org\u002F10.1098\u002Frsta.2015.0202.\nBauer RJ. NONMEM tutorial part I: description of commands and options, with simple examples of population analysis. CPT Pharmacometrics Syst Pharmacol. 2019;8:525–37. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fpsp4.12404.\nGomeni R, Bressolle-Gomeni F. Comparison of alternative population modeling approaches for implementing a level a IVIVC and for assessing the time-scaling factor using deconvolution and convolution-based methods. AAPS J. 2020;22(3):67. https:\u002F\u002Fdoi.org\u002F10.1208\u002Fs12248-020-00445-0.\nGomeni R, Bressolle-Gomeni F. Deconvolution analysis by non-linear regression using a convolution-based model: comparison of nonparametric and parametric approaches. AAPS J. 2019;22(1):9. https:\u002F\u002Fdoi.org\u002F10.1208\u002Fs12248-019-0389-8.\nCheng CL, Yu LX, Lee HL, Yang CY, Lue CS, Chou CH. Biowaiver extension potential to BCS class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet. Eur J Pharm Sci. 2004;22(4):297–304. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.ejps.2004.03.016.\nNajib N, Idkaidek N, Beshtawi M, Bader M, Admour I, Alam SM, et al. Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon & Glucophage)--in healthy human volunteers. Biopharm Drug Dispos. 2002;23(7):301–6. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fbdd.326.\nCenter for Drug Evaluation and Research. Guidance for industry: bioanalytical method validation. US Food and Drug Administration; 2018.\nDi Maio S, Carrier RL. Gastrointestinal contents in fasted state and post-lipid ingestion: in vivo measurements and in vitro models for studying oral drug delivery. J Control Release. 2011;151(2):110–22. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jconrel.2010.11.034.\nCosta P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123–33. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fs0928-0987(01)00095-1.\nGaynor C, Dunne A, Davis J. A comparison of the prediction accuracy of two IVIVC modelling techniques. J Pharm Sci. 2008;97(8):3422–32. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fjps.21220.\nGillespie WR. Convolution-based approaches for in vivo-in vitro correlation modeling. Adv Exp Med Biol. 1997;423:53–65. https:\u002F\u002Fdoi.org\u002F10.1007\u002F978-1-4684-6036-0_5.\nBuchwald P. Direct, differential-equation-based in-vitro-in-vivo correlation (IVIVC) method. J Pharm Pharmacol. 2003;55(4):495–504. https:\u002F\u002Fdoi.org\u002F10.1211\u002F002235702847.\nCostello C, Rossenu S, Vermeulen A, Cleton A, Dunne A. A time scaling approach to develop an in vitro-in vivo correlation (IVIVC) model using a convolution-based technique. J Pharmacokinet Pharmacodyn. 2011;38(5):519–39. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs10928-011-9206-4.\nMargolskee A, Darwich AS, Galetin A, Rostami-Hodjegan A, Aarons L. Deconvolution and IVIVC: exploring the role of rate-limiting conditions. AAPS J. 2016;18(2):321–32. https:\u002F\u002Fdoi.org\u002F10.1208\u002Fs12248-015-9849-y.\nWAGNER JG, NELSON E. Per cent absorbed time plots derived from blood level and\u002For urinary excretion data. J Pharm Sci. 1963;52:610–1. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fjps.2600520629.\nLoo JC, Riegelman S. New method for calculating the intrinsic absorption rate of drugs. J Pharm Sci. 1968;57(6):918–28. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fjps.2600570602.\nGomeni R, Fang LL, Bressolle-Gomeni F, Spencer TJ, Faraone SV, Babiskin A. A general framework for assessing in vitro\u002Fin vivo correlation as a tool for maximizing the benefit-risk ratio of a treatment using a convolution-based modeling approach. CPT Pharmacometrics Syst Pharmacol. 2019;8(2):97–106. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fpsp4.12378.\nHovorka R, Chappell MJ, Godfrey KR, Madden FN, Rouse MK, Soons PA. CODE: a deconvolution program implementing a regularization method of deconvolution constrained to non-negative values. Description and pilot evaluation. Biopharm Drug Dispos. 1998;19(1):39–53. https:\u002F\u002Fdoi.org\u002F10.1002\u002F(sici)1099-081x(199801)19:1\u003C39::aid-bdd73>3.0.co;2-m.\nCenter for Drug Evaluation and Research. Guidance for industry: the use of physiologically based pharmacokinetic analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. US Food and Drug Administration; 2020.\nBalan G, Timmins P, Greene DS, Marathe PH. In vitro-in vivo correlation (IVIVC) models for metformin after administration of modified-release (MR) oral dosage forms to healthy human volunteers. J Pharm Sci. 2001;90(8):1176–85. https:\u002F\u002Fdoi.org\u002F10.1002\u002Fjps.1071.\nFuchs A, Leigh M, Kloefer B, Dressman JB. Advances in the design of fasted state simulating intestinal fluids: FaSSIF-V3. Eur J Pharm Biopharm. 2015;94:229–40. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.ejpb.2015.05.015.",{"VOID":997},"10.1208\u002Fs12248-021-00559-z","PUBLICATION","Auto Verify","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1208\u002Fs12248-021-00559-z",[1002,1018,1033,1046,1059,1072,1087],{"id":1003,"sortIndex":32,"researcher":28,"roles":1004,"affiliations":1006,"properties":1015,"displayName":1017,"givenName":28,"familyName":28},"41acc1c9-23dd-4e3d-96be-30d397d86f18",[1005],"AUTHOR",[1007],{"id":1008,"sortIndex":32,"affiliation":1009,"properties":28},"704ef621-25f1-48bb-8acc-5fea1dd4822c",{"id":1008,"createTime":28,"updateTime":28,"relativeEntities":1010,"slug":28,"properties":1011,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1014,"statistic":28},[],{"title":1012},{"VI":1013},"School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, People’s 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purpose of this study was to evaluate the value of model-based, quantitative decision making during the development of gemcabene, a novel lipid-altering agent. The decisions were driven by a model of the likely clinical profile of gemcabene in comparison with its competitors, such as 3-hydroxymethylglutaryl coenzyme A reductase inhibitors (statins), the cholesterol absorption inhibitor ezetimibe, and their combination. Dose-response models were developed for the lipid effects (low-density lipoprotein cholesterol [LDL-C] and high-density lipoprotein cholesterol); adverse effects, such as persistent alanine aminotransferase elevation and myalgia; tolerability issues, such as headache; and risk reduction for coronary artery disease-related events for 5 statins, ezetimibe, gemcabene, and their combinations. The integrated model was based on the joint analysis of publicly available summary-level data and proprietary patient-level data and included information from almost 10,000 patients. The model was made available and accessible to the development team by using the Pharsight Drug Model Explorer model visualization technology. The modeling greatly enhanced the understanding of the clinical profile of gemcabene when given alone or in combination with a statin. The interaction between statins and gemcabene for the LDL-C lowering effect was found to be significantly different from the interaction between statins and ezetimibe. Ezetimibe was found to have a pharmacological-independent interaction resulting in additional LDL-C lowering over the entire statin dose range. The gemcabene interaction was found to be less than independent, resulting in almost no additional LDL-C lowering at high-statin doses, although the drug has a significant LDL-C effect when administered alone or in combination with a low dose of a statin. The quick availability of the model after completion of the first phase II trial in the target patient population and the ability of the team to explore the potential clinical efficacy and safety of gemcabene in comparison with alternative treatment options facilitated a quick decision to stop development.",{"EN":1162},"Model-based development of gemcabene, a new lipid-altering agent",{"VOID":1164},"Bays HB, McKenney JM, Dujovne CA, et al. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol.Am J Cardiol. 2003;92:538–543.\nGrundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel Ill guidelines.Circulation. 2004;110:227–239.\nNormand S-L. Meta-analysis: formulating, evaluating, combining, and reporting.Stat Med. 1999;18:321–359.\nBerry DA, Berry SM, McKellar J, Pearson TA. Comparison of the dose-response relationships of 2 lipid-lowering agents: a Bayesian meta-analysis.Am Heart J. 2003;145:1036–1045.\nMandema JW, Cox E, Alderman J. Therapeutic benefit of Eletriptan compared to Sumatriptan for the acute relief of migraine pain—results of a model-based meta-analysis that accounts for encapsulation.Cephalalgia. 2005;25:715–725.\nNawrocki JW, Weiss SR, Davidson MH, et al. Reductions of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor.Arterioscler Thromb Vasc Biol. 1995;15:678–682.\nU.S. Food and Drug Administration, 2002. NDA 21-445. Zetia (ezetimibe) Medical Reviews. CDER, FDA.\nDavidson M, McKenney J, Stein E, et al. Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I.Am J Cardiol. 1997;79:1475–1481.\nJones P, Kafonek S, Laurora I, Hunninghake D. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (The CURVES Study).Am J Cardiol. 1998;81:582–587.\nU.S. Food and Drug Administration, 1996. NDA 20-702. Lipitor (atorvastatin) Medical Reviews. CDER, FDA.\nOlsson AG, Pears J, McKellar J, Mizan J, Raza A. Effect of Rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia.Am J Cardiol. 2001;88:504–508.\nPaoletti R, Fahmy M, Mahla G, Mizan J, Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with Pravastatin and Sim vastatin in hypercholesterolaemic patients: a randomized, double-blind study.J Cardiovasc Risk. 2001;8:383–390.\nBays HE, Moore PB, Drehobl MA, et al. Effectiveness and tolerability of Ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies.Clin Ther. 2001;23:1209–1230.\nDavidson M, Ma P, Stein EA, et al. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with Rosuvastatin versus Atorvastatin in patients with type IIa or IIb hypercholesterolemia.Am J Cardiol. 2002;89:268–275.\nBlasetto JW, Stein EA, Brown WV, Chitra R, Raza A. Efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups.Am J Cardiol. 2003;91:3–10.\nOlsson AG, Istad H, Luurila O, et al. Effects of Rosuvastatin and Atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia.Am Heart J.. 2002;144:1044–1051.\nBrown WV, Bays HE, Hassman DR, et al. Efficacy and safety of Rosuvastatin compared with Pravastatin and Simvastatin in patients with hypercholesterolemia: a randomized, double-blind, 52-week trial.Am Heart J.. 2002;144:1036–1043.\nDujovne CA, Ettinger MP, McNeer JF, et al. Efficacy and safety of a potent new selective cholesterol absorption inhibitor, Ezetimibe, in patients with primary hypercholesterolemia.Am J Cardiol. 2002;90:1092–1097.\nDavidson MH, McGarry T, Bettis R, et al. Ezetimibe coadministered with Simvastatin in patients with primary hypercholesterolemia.J Am Coll Cardiol. 2002;40:2125–2134.\nSchneck DW, Knopp RH, Ballantyne CM, McPherson R, Chitra RR, Simonson SG. Comparative effects of Rosuvastatin and Atorvastatin across their dose ranges in patients with hypercholesterolemia and without active arterial disease.Am J Cardiol. 2003;91:33–41.\nKnopp RH, Gitter H, Truitt T, et al. Effects of Ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia.Eur Heart J.. 2003;24:729–741.\nBallantyne CM, Houri J, Notarbartolo A, et al. Effect of Ezetimibe coadministered with Atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial.Circulation. 2003;107:2409–2415.\nMelani L, Mills R, Hassman D, et al. Efficacy and safety of Ezetimibe coadministered with Pravastatin in patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial.Eur Heart J. 2003;24:717–728.\nKerzner B, Corbelli J, Sharp S, et al. Efficacy and safety of Ezetimibe coadministered with Lovastatin in primary hypercholesterolemia.Am J Cardiol. 2003;91:418–424.\nIllingworth DR, Erkelens DW, Keller U, Thompson GR, Tikkanen MJ. Defined daily doses in relation to hypolipidaemic efficacy of lovastatin, pravastatin, and simvastatin.Lancet. 1994;343:1554–1556.\nLaw MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.BMJ. 2003;326:1423–1430.",{"VOID":1166},"10.1208\u002Faapsj070352","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1208\u002Faapsj070352",[1169,1184,1199,1212,1225,1238,1251],{"id":1170,"sortIndex":32,"researcher":28,"roles":1171,"affiliations":1172,"properties":1181,"displayName":1183,"givenName":28,"familyName":28},"7eb71f64-467b-44ee-94a4-29de85ef9989",[1005],[1173],{"id":1174,"sortIndex":32,"affiliation":1175,"properties":28},"c8fa13a0-6109-47d4-836f-90dba4cd0fc0",{"id":1174,"createTime":28,"updateTime":28,"relativeEntities":1176,"slug":28,"properties":1177,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1180,"statistic":28},[],{"title":1178},{"VI":1179},"Pharsight Corporation, Mountain View",[],{"title":1182},{"VI":1183},"Jaap W. 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changes during a biological drug product life cycle occur often; one common change is that of the manufacturing site. Comparability studies may be required to ensure that the changes will not affect the pharmacokinetic properties of the drug. In addition, the bioanalytical method for sample analysis may evolve during the course of drug development. This paper illustrates the scenario of both manufacturing and bioanalytical method changes encountered during the development of denosumab, a fully human monoclonal antibody which inhibits bone resorption by targeting RANK Ligand. Here, we present a rational approach to address the bioanalytical method changes and provide considerations for method validation and sample analysis in support of biocomparability studies. An updated and improved ELISA method was validated, and its performance was compared to the existing method. The analytical performances, i.e., the accuracy and precision of standards and validation samples prepared from both manufacturing formulation lots, were evaluated and found to be equivalent. One of the lots was used as the reference standard for sample analysis of the biocomparability study. This study was sufficiently powered using a parallel design. The bioequivalence acceptance criteria for small molecule drugs were adopted. The pharmacokinetic parameters of the subjects dosed with both formulation lots were found to be comparable.",{"EN":1324},"Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes",{"VOID":1326},"Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22(11):1383–91.\nGuidance for Industry; Bioavailability and Bioequivalence Studies for Orally Administrated Drug Product- General Considerations; U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER), March 2003, Revision 1. http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FDrugs\u002F...\u002FGuidances\u002Fucm070124.pdf.\nICH. International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use (1999). ICH Harmonized Tripartite Guideline Q6B Specifications: Test Procedures And Acceptance Criteria For Biotechnological\u002FBiological Products Q6b CPMP\u002FICH\u002F365\u002F96. (1999). ICH. ICH Harmonized Tripartite Guideline Q5E Comparability of Biotechnological\u002FBiological Products Subject to Changes in their Manufacturing Process CPMP\u002FICH\u002F5721\u002F03. (2004).\nEMEA. Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process: non-clinical and clinical issues. London, 24 January 2007. Doc. Ref. EMEA\u002FCHMP\u002FBMWP\u002F101695\u002F2006.\nFDA Guidance for Industry (Draft Guidance): Comparability Protocols- Protein Drug Products and Biological Products- Chemsitrty, Manufacturing, and Controls Information, September 2003. http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FDrugs\u002FGuidanceComplianceRegulatoryInformation\u002FGuidances\u002Fucm070262.pdf.\nDeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20(11):1885–900.\nLee JW, Wang YM, Moxness M, DeSilva B. Bioanalytical considerations in the comparability assessment of biotherapeutics. Bioanalysis. 2011;3(6):613–22.\nFDA Guidance for Industry; CDER; Statistical Approaches to Establishing Bioequivalence. January 2001. http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FDrugs\u002F...\u002FGuidances\u002Fucm070244.pdf\nKelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules. AAPS J. 2007;9(2):E156–63.\nBekker PJ, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004;19(7):1059–66.\nYasuda H, et al. Osteoclast differentiation factor is a ligand for osteoprotegerin osteoclastogenesis-inhibitory factor and is identical to TRANCE\u002FRANKL. Proc Natl Acad Sci USA. 1998;95:3597–602.\nFuller K, et al. TRANCE is necessary and sufficient for osteoblast-mediated activation of bone resorption in osteoclasts. J Exp Med. 1998;188:997–1001.\nLacey DL, et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998;93:165–76.\nLacey DL, et al. Osteoprotegerin ligand modulates murine osteoclast survival in vitro and in vivo. Am J Pathol. 2000;157:435–4.\nBovle WJ, et al. Osteoclast differentiation and activation. Nature. 2003;423:337–42.\nBlock GA, Bone HG, Fang L, Lee E, Padhi D. A single-dose study of denosumab in patients with various degree of renal impairment. J Bone Miner Res. 2012;7(7):1471–9.\nLipton A, Ali SM, Leitzel K, Chinchilli V, Witters L, Engle L, Holloway D, Bekker P, Dunstan CR. Serum osteoprotegerin levels in healthy controls and cancer patients. Clin Cancer Res. 2002;8:2306.\nPandya K. Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification. J Pharm Biomed Anal. 2010;53(3):623–30. 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After administration, metapristone is found to be the most predominant metabolite of mifepristone. We hypothesized that adhesion of circulating tumor cells (CTCs) to vascular endothelial bed is a crucial starting point in metastatic cascade, and that metapristone can serve as a cancer metastatic chemopreventive agent that can interrupt adhesion and invasion of CTCs to the intima of microvasculature. In the present study, we modified the synthesis procedure to produce grams of metapristone, fully characterized its spectral properties and in vitro cellular activities, including its cytostatic effects, cell cycle arrest, mitochondrial membrane potential, and apoptosis on human colorectal cancer HT-29 cells. Metapristone concentration dependently interrupted adhesion of HT-29 cells to endothelial cells. Metapristone may potentially be a useful agent to interrupt metastatic initiation.",{"EN":1529},"Synthesis, Spectral Characterization, and In Vitro Cellular Activities of Metapristone, a Potential Cancer Metastatic Chemopreventive Agent Derived from Mifepristone (RU486)",{"VOID":1531},"Fleseriu M, Biller BM, Findling JW, Molitch ME, Schteingart DE, Gross C, et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocr Metab. 2012;97(6):2039–49.\nEl Etreby MF, Liang YY, Wrenn RW, Schoenlein PV. Additive effect of mifepristone and tamoxifen on apoptotic pathways in MCF-7 human breast cancer cells. Breast Cancer Res Tr. 1998;51(2):149–68.\nFiscella J, Bonfiglio T, Winters P, Eisinger SH, Fiscella K. Distinguishing features of endometrial pathology after exposure to the progesterone receptor modulator mifepristone. Hum Pathol. 2011;42(7):947–53.\nFried G, Meister B, Râdestad A. Peptide-containing nerves in the human pregnant uterine cervix: an immunohistochemical study exploring the effect of RU 486 (mifepristone). Hum Reprod. 1990;5(7):870–6.\nLigr M, Li Y, Logan SK, Taneja S, Melamed J, Lepor H, et al. Mifepristone inhibits GRβ coupled prostate cancer cell proliferation. J Urol. 2012;188(3):981–8.\nGoel N, Malik R, Rathi B, Bhaskaran S, Rajaram S, Mehta S, et al. Pregnancy with metastatic gastrointestinal stromal tumor (GIST) on imatinib chemotherapy: an oncologist’s nightmare and obstetrician’s dilemma. J Gastroint Cancer. 2013;44(1):115–7.\nWang Y, Yang D, Song L, Li T, Yang J, Zhang X, et al. Mifepristone-inducible caspase-1 expression in mouse embryonic stem cells eliminates tumor formation but spares differentiated cells in vitro and in vivo. Stem Cells. 2012;30(2):169–79.\nCher ML, Towler DA, Rafii S, Rowley D, Donahue HJ, Keller E, et al. Cancer interaction with the bone microenvironment: a workshop of the National Institutes of Health Tumor Microenvironment Study Section. Am J Pathol. 2006;168(5):1405–12.\nWempe SL, Gamarra-Luques CD, Telleria CM. Synergistic lethality of mifepristone and LY294002 in ovarian cancer cells. Cancer Growth Metast. 2013;6:1–13.\nChen JZ, Wang JC, Xu JG, Shao JW, Jia L. Pharmaceutical characteristics of mifepristone: from terminating pregnancy to preventing cancer metastasis. Med Res Rev 2013 (in press).\nde Moor JS, Mariotto AB, Parry C, Alfano CM, Padgett L, Kent EE, et al. Cancer survivors in the United States: prevalence across the survivorship trajectory and implications for care. Cancer Epidem Biomar. 2013;22(4):561–70.\nHeikinheimo O, Haukkamaa M, Lahteenmaki P. Distribution of RU 486 and its demethylated metabolites in humans. J Clin Endocrinol Metab. 1989;68(2):270–5.\nShi YE, Ye ZH, He CH, Zhang GQ, Xu JQ, Van Look PF, et al. Pharmacokinetic study of RU 486 and its metabolites after oral administration of single doses to pregnant and non-pregnant women. Contraception. 1993;48(2):133–49.\nTeng YN, Dong RQ, Wang BJ, Liu HJ, Jiang ZM, Wei CM, et al. Determinations of mifepristone and its metabolites and their pharmacokinetics in healthy female Chinese subjects. Acta Pharm Sin. 2011;46(10):1241–5.\nHeikinheimo O, Kontula K, Croxatto H, Spitz I, Luukkainen T, Lahteenmaki P. Plasma concentrations and receptor binding of RU 486 and its metabolites in humans. J Steroid Biochem. 1987;26(2):279–84.\nHaier J, Nasralla M, Nicolson GL. Cell surface molecules and their prognostic values in assessing colorectal carcinomas. Ann Surg. 2000;231(1):11–24.\nPermezel JM, Lenton EA, Roberts I, Cooke ID. Acute effects of progesterone and the antiprogestin RU 486 on gonadotropin secretion in the follicular phase of the menstrual cycle. J Clin Endocrinol Metab. 1989;68(5):960–5.\nLash GE, Fitzpatrick TE, Graham CH. Effect of hypoxia on cellular adhesion to vitronectin and fibronectin. Biochem Bioph Res Co. 2001;287(3):622–9.\nArck P, Hagen E, Hildebrandt M, Klapp B, Hertwig K. Pregnancy as a model of controlled invasion might be attributed to the ratio of CD3\u002FCD8 to CD56. Am J Reprod Immunol. 2000;44(1):1–8.\nMurray MJ, Lessey BA. Embryo implantation and tumor metastasis: common pathways of invasion and angiogenesis. Semin Reprod Endocrinol. 1999;17(3):275–90.\nFitzpatrick TE, Lash GE, Yanaihara A, Charnock-Jones DS, Macdonald-Goodfellow SK, Graham CH. Inhibition of breast carcinoma and trophoblast cell invasiveness by vascular endothelial growth factor. Exp Cell Res. 2003;283(2):247–55.\nJanneau JL, Maldonado-Estrada J, Tachdjian G, Miran I, Motté N, Saulnier P, et al. Transcriptional expression of genes involved in cell invasion and migration by normal and tumoral trophoblast cells. J Clin Endocrinol Metab. 2002;87(11):5336–9.\nHödl C, Raunegger K, Strommer R, Ecker GF, Kunert O, Sturm S, et al. Syntheses and antigestagenic activity of Mifepristone derivatives. J Med Chem. 2009;52(5):1268–74.\nHödl C, Strauss WS, Sailer R, Seger C, Steiner R, Haslinger E, et al. A novel, high-affinity, fluorescent progesterone receptor antagonist. Synthesis and in vitro studies. Bioconjug Chem. 2004;15(2):359–65.\nShao J, Dai Y, Zhao W, Xie J, Xue J, Ye J, et al. Intracellular distribution and mechanisms of actions of photosensitizer zinc(II)-phthalocyanine solubilized in Cremophor EL against human hepatocellular carcinoma HepG2 cells. Cancer Lett. 2013;330(1):49–56.\nJaffe EA, Nachman RL, Becker CG, Minick CR. Culture of human endothelial cells derived from umbilical veins. Identification by morphologic and immunologic criteria. J Clin Invest. 1973;52(11):2745–56.\nZamzami N, Marchetti P, Castedo M, Decaudin D, Macho A, Hirsch T, et al. Sequential reduction of mitochondrial transmembrane potential and generation of reactive oxygen species in early programmed cell death. J Exp Med. 1995;182(2):367–77.\nShao J, Xue J, Dai Y, Liu H, Chen N, Jia L, et al. Inhibition of human hepatocellular carcinoma HepG2 by phthalocyanine photosensitiser PHOTOCYANINE: ROS production, apoptosis, cell cycle arrest. Eur J Cancer. 2012;48(13):2086–96.\nSchoch GA, D'Arcy B, Stihle M, Burger D, Bär D, Benz J, et al. Molecular switch in the glucocorticoid receptor: active and passive antagonist conformations. J Mol Biol. 2010;395(3):568–77.\nHoner C, Nam K, Fink C, Marshall P, Ksander G, Chatelain RE, et al. Glucocorticoid receptor antagonism by cyproterone acetate and RU486. Mol Pharmacol. 2003;63(5):1012–20.\nvon Geldern TW, Tu N, Kym PR, Link JT, Jae HS, Lai C, et al. Liver-selective glucocorticoid antagonists: a novel treatment for type 2 diabetes. J Med Chem. 2004;47(17):4213–30.\nMacindoe G, Mavridis L, Venkatraman V, Devignes MD, Ritchie DW. HexServer: an FFT-based protein docking server powered by graphics processors. Nucleic Acids Res. 2010;38(Web Server issue):W445–9.\nLi DQ, Wang ZB, Bai J, Zhao J, Wang Y, Hu K, et al. Effects of mifepristone on invasive and metastatic potential of human gastric adenocarcinoma cell line MKN-45 in vitro and in vivo. World J Gastroenterol. 2004;10(12):1726–9.\nSaha P, Hödl C, Strauss WS, Steiner R, Goessler W, Kunert O, et al. Synthesis, in vitro progesterone receptors affinity of gadolinium containing mifepristone conjugates and estimation of binding sites in human breast cancer cells. Bioorgan Med Chem. 2010;18(5):1891–8.\nMa Y, Katiyar P, Jones LP, Fan S, Zhang Y, Furth PA, et al. The breast cancer susceptibility gene BRCA1 regulates progesterone receptor signaling in mammary epithelial cells. Mol Endocrinol. 2006;20(1):14–34.\nZhang L, Wang XM, Jiao XM, Liu SS. The effect of superoxide ainon on transmembrane potential and proton transfer of myocardial mitochondria. Chinese J Pathophysiol. 1996;12(2):181–4.\nVermes I, Haanen C, Steffens-Nakken H, Reutellingsperger C. A novel assay for apoptosis flow cytometric detection of phosphatidylserine expression on early apoptotic cells using fluorescein labelled annexin V. J Immunol Methods. 1995;184(1):39–51.\nFerretti C, Bruni L, Dangles-Marie V, Pecking A, Bellet D. Molecular circuits shared by placental and cancer cells, and their implications in the proliferative, invasive and migratory capacities of trophoblasts. Hum Reprod Update. 2007;13(2):121–41.\nEllis LM, Radinsky R, Fidler IJ. Recent advances in the biology of cancer invasion and metastasis. Surgical Oncology: Contemporary Principles and Practice. 2001. p. 101–22.",{"VOID":1533},"10.1208\u002Fs12248-013-9559-2","http:\u002F\u002Flink.springer.com\u002F10.1208\u002Fs12248-013-9559-2",[1536,1551,1573,1586,1599,1612,1625,1638,1651,1664],{"id":1537,"sortIndex":32,"researcher":28,"roles":1538,"affiliations":1539,"properties":1548,"displayName":1550,"givenName":28,"familyName":28},"90f170aa-d3cc-48f7-b3f7-eec355415431",[1005],[1540],{"id":1541,"sortIndex":32,"affiliation":1542,"properties":28},"efd8487d-d51d-4e86-8b03-a83378fdfdd4",{"id":1541,"createTime":28,"updateTime":28,"relativeEntities":1543,"slug":28,"properties":1544,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1547,"statistic":28},[],{"title":1545},{"VI":1546},"Cancer Metastasis Alert and Prevention Center, College of Chemistry and Chemical Engineering, Fuzhou University, Fuzhou, China",[],{"title":1549},{"VI":1550},"Jichuang 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management of type 2 diabetes mellitus (T2DM), a complex and chronic disease, requires a combination of anti-hyperglycemic and anti-inflammatory agents. Here, we have conceptualized and tested an integrated “closed-loop mimic” in the form of a glucose-responsive microgel (GRM) based on chitosan, comprising conventional insulin (INS) and curcumin-laden nanoparticles (nCUR) as a potential strategy for effective management of the disease. In addition to mimicking the normal, on-demand INS secretion, such delivery systems display an uninterrupted release of nCUR to combat the inflammation, oxidative stress, lipid metabolic abnormality, and endothelial dysfunction components of T2DM. Additives such as gum arabic (GA) led to a fivefold increased INS loading capacity compared to GRM without GA. The GRMs showed excellent in vitro on-demand INS release, while a constant nCUR release is observed irrespective of glucose concentrations. Thus, this study demonstrates a promising drug delivery technology that can simultaneously, and at physiological\u002Fpathophysiological relevance, deliver two drugs of distinct physicochemical attributes in the same formulation. \n                  \n                    \n                      \n                    \n                  \n                ",{"EN":1735},"Glucose-Responsive Microgel Comprising Conventional Insulin and Curcumin-Laden Nanoparticles: a Potential Combination for Diabetes Management",{"VOID":1737},"Athithan L, Gulsin GS, McCann GP, Levelt E. Diabetic cardiomyopathy: pathophysiology, theories and evidence to date. World J Diabetes. 2019;10(10):490–510.\nSatin LS, Butler PC, Ha J, Sherman AS. Pulsatile insulin secretion, impaired glucose tolerance and type 2 diabetes. Mol Aspects Med. 2015;42:61–77.\nBoussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, Lafont S, Bergeonneau C, Kassai B, et al. 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Injectable thermosensitive PEG-g-chitosan hydrogel for ocular delivery of vancomycin and prednisolone. J Drug Deliv Sci. 2023;83:104385.\nBhuiyan MH, Clarkson AN, Ali MA. Optimization of thermoresponsive chitosan\u002Fβ-glycerophosphate hydrogels for injectable neural tissue engineering application. Colloids Surf B Biointerfaces. 2023;224: 113193.\nVermonden T, Censi R, Hennink WE. Hydrogels for protein delivery. Chem Rev. 2012;112(5):2853–88.\nSarkar S, Das D, Dutta P, Kalita J, Wann SB, Manna P. Chitosan: a promising therapeutic agent and effective drug delivery system in managing diabetes mellitus. Carbohydr Polym. 2020;247: 116594.\nDelmar K, Bianco-Peled H. Composite chitosan hydrogels for extended release of hydrophobic drugs. Carbohyd Polym. 2016;136:570–80.\nMahanta AK, Maiti P. Injectable hydrogel through hydrophobic grafting on chitosan for controlled drug delivery. ACS Appl Bio Mater. 2019;2(12):5415–26.\nKashyap N, Viswanad B, Sharma G, Bhardwaj V, Ramarao P, Ravi Kumar MN. Design and evaluation of biodegradable, biosensitive in situ gelling system for pulsatile delivery of insulin. Biomaterials. 2007;28(11):2051–60.\nGanugula R, Nuthalapati NK, Dwivedi S, Zou D, Arora M, Friend R, et al. Nanocurcumin combined with insulin alleviates diabetic kidney disease through P38\u002FP53 signaling axis. J Control Release. 2023;353:621–33.\nGanugula R, Arora M, Dwivedi S, Chandrashekar DS, Varambally S, Scott EM, et al. Systemic anti-inflammatory therapy aided by curcumin-laden double-headed nanoparticles combined with injectable long-acting insulin in a rodent model of diabetes eye disease. ACS Nano. 2023;17(7):6857–74.\nDwivedi S, Gottipati A, Ganugula R, Arora M, Friend R, Osburne R, et al. Oral nanocurcumin alone or in combination with insulin alleviates STZ-induced diabetic neuropathy in rats. 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Br J Pharmacol. 2017;174(13):2074–84.\nGrama CN, Suryanarayana P, Patil MA, Raghu G, Balakrishna N, Kumar MR, et al. Efficacy of biodegradable curcumin nanoparticles in delaying cataract in diabetic rat model. PLoS ONE. 2013;8(10): e78217.\nGrama CN, Venkatpurwar VP, Lamprou DA, Ravi KM. Towards scale-up and regulatory shelf-stability testing of curcumin encapsulated polyester nanoparticles. Drug Deliv Transl Res. 2013;3:286–93.\nShaikh J, Ankola D, Beniwal V, Singh D, Kumar MR. Nanoparticle encapsulation improves oral bioavailability of curcumin by at least 9-fold when compared to curcumin administered with piperine as absorption enhancer. Eur J Pharm Sci. 2009;37(3–4):223–30.\nIbekwe CA, Oyatogun GM, Esan TA, Oluwasegun KM. Synthesis and characterization of chitosan\u002Fgum arabic nanoparticles for bone regeneration. Am J Mater Sci Eng. 2017;5(1):28–36.\nGill HS, Prausnitz MR. Does needle size matter? 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Biomaterials. 2021;267: 120458.\nLiu Y, Wang Y, Yao Y, Zhang J, Liu W, Ji K, et al. Glucose-responsive charge-switchable lipid nanoparticles for insulin delivery. Angew Chem Int Ed Engl. 2023;62(20): e202303097.\nPhillips GO, Williams PA. Handbook of hydrocolloids. Elsevier; 2nd Edition; 2009.\nSharma G, Sharma S, Kumar A, Ala’a H, Naushad M, Ghfar AA, et al. Guar gum and its composites as potential materials for diverse applications: a review. Carbohydr Polym. 2018;199:534–45.\nSánchez-Cid P, Jiménez-Rosado M, Alonso-González M, Romero A, Perez-Puyana V. Applied rheology as tool for the assessment of chitosan hydrogels for regenerative medicine. Polymers. 2021;13(13):2189.\nLee J, Ko JH, Mansfield KM, Nauka PC, Bat E, Maynard HD. Glucose-responsive trehalose hydrogel for insulin stabilization and delivery. Macromol Biosci. 2018;18(5): e1700372.\nRumsey SC, Galeano NF, Arad Y, Deckelbaum RJ. Cryopreservation with sucrose maintains normal physical and biological properties of human plasma low density lipoproteins. J Lipid Res. 1992;33(10):1551–61.",{"VOID":1739},"10.1208\u002Fs12248-023-00839-w","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1208\u002Fs12248-023-00839-w",[1742,1775,1811,1845,1906],{"id":1743,"sortIndex":32,"researcher":28,"roles":1744,"affiliations":1745,"properties":1772,"displayName":1774,"givenName":28,"familyName":28},"38a68e58-9adf-4b61-897e-52a40afb5ad3",[1005],[1746,1754,1763],{"id":1747,"sortIndex":32,"affiliation":1748,"properties":28},"5a15c69d-1fbb-4334-9727-2853d5259175",{"id":1747,"createTime":28,"updateTime":28,"relativeEntities":1749,"slug":28,"properties":1750,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1753,"statistic":28},[],{"title":1751},{"VI":1752},"The Center for Convergent Bioscience and Medicine (CCBM), The University of Alabama, Tuscaloosa, USA",[],{"id":1755,"sortIndex":40,"affiliation":1756,"properties":1762},"18a2f47b-2dcf-4527-a268-3d3171d5696b",{"id":1755,"createTime":28,"updateTime":28,"relativeEntities":1757,"slug":28,"properties":1758,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1761,"statistic":28},[],{"title":1759},{"VI":1760},"Bioscience and Medicine Initiative, College of Community Health Sciences, The University of Alabama, Tuscaloosa, USA",[],{},{"id":1764,"sortIndex":123,"affiliation":1765,"properties":1771},"643b487b-cfd4-45c0-806f-e6612480705f",{"id":1764,"createTime":28,"updateTime":28,"relativeEntities":1766,"slug":28,"properties":1767,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":1770,"statistic":28},[],{"title":1768},{"VI":1769},"Alabama Life Research Institute, The University of Alabama, Tuscaloosa, USA",[],{},{"title":1773},{"VI":1774},"Ingrid M. 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human intestinal proton-coupled peptide transporter, hPEPT1 (SLC15A1), has been identified as an absorptive transporter for both drug substances and prodrugs. An understanding of the prerequisites for transport has so far been obtained from models based on competition experiments. These models have limited value for predicting substrate translocation via hPEPT1. The aim of the present study was to investigate the requirements for translocation via hPEPT1. A set of 55 tripeptides was selected from a principal component analysis based on VolSurf descriptors using a statistical design. The majority of theses tripeptides have not previously been investigated. Translocation of the tripeptides via hPEPT1 was determined in a MDCK\u002FhPEPT1 cell-based translocation assay measuring substrate-induced changes in fluorescence of a membrane potential-sensitive probe. Affinities for hPEPT1 of relevant tripeptides were determined by competition studies with [14C]Gly-Sar in MDCK\u002FhPEPT1 cells. Forty tripeptides were found to be substrates for hPEPT1, having K\n                m\n                app values in the range 0.4–28 mM. Eight tripeptides were not able to cause a substrate-induced change in fluorescence in the translocation assay and seven tripeptides interacted with the probe itself. The conformationally restricted tripeptide Met-Pro-Pro was identified as a novel high-affinity inhibitor of hPEPT1. We also discovered the first tripeptide (Asp-Ile-Arg) that was neither a substrate nor an inhibitor of hPEPT1. To rationalise the requirements for transport, a quantitative structure–activity relationship model correlating K\n                m\n                app values with VolSurf descriptors was constructed. This is, to our knowledge, the first predictive model for the translocation of tripeptides via hPEPT1.",{"EN":2000},"A Quantitative Structure–Activity Relationship for Translocation of Tripeptides via the Human Proton-Coupled Peptide Transporter, hPEPT1 (SLC15A1)",{"VOID":2002},"Adibi SA. Intestinal transport of dipeptides in man: relative importance of hydrolysis and intact absorption. J Clin Invest. 1971;50:2266–75.\nFei YJ, Kanai Y, Nussberger S, Ganapathy V, Leibach FH, Romero MF et al. Expression cloning of a mammalian proton-coupled oligopeptide transporter. Nature. 1994;368:563–6.\nOgihara H, Saito H, Shin BC, Terado T, Takenoshita S, Nagamachi Y et al. Immuno-localization of H+\u002Fpeptide cotransporter in rat digestive tract. Biochem Biophys Res Commun. 1996;220:848–52.\nAddison JM, Burston D, Dalrymple JA, Matthews DM, Payne JW, Sleisenger MH et al. A common mechanism for transport of di- and tri-peptides by hamster jejunum in vitro. Clin Sci Mol Med. 1975;49:313–22.\nBalimane PV, Tamai I, Guo A, Nakanishi T, Kitada H, Leibach FH et al. Direct evidence for peptide transporter (PepT1)-mediated uptake of a nonpeptide prodrug, valacyclovir. Biochem Biophys Res Commun. 1998;250:246–51.\nde Vrueh RL, Smith PL, Lee CP. Transport of L-valine-acyclovir via the oligopeptide transporter in the human intestinal cell line, Caco-2. J Pharmacol Exp Ther. 1998;286:1166–70.\nNakashima E, Tsuji A, Mizuo H, Yamana T. Kinetics and mechanism of in vitro uptake of amino-beta-lactam antibiotics by rat small intestine and relation to the intact-peptide transport system. Biochem Pharmacol. 1984;33:3345–52.\nSugawara M, Huang W, Fei YJ, Leibach FH, Ganapathy V, Ganapathy ME. Transport of valganciclovir, a ganciclovir prodrug, via peptide transporters PEPT1 and PEPT2. J Pharm Sci. 2000;89:781–9.\nNielsen CU, Brodin B, Jorgensen FS, Frokjaer S, Steffansen B. Human peptide transporters: therapeutic applications. Expert Opin Ther Pat. 2002;12:1329–50.\nNielsen CU, Vabeno J, Andersen R, Brodin B, Steffansen B. Recent advances in therapeutic applications of human peptide transporters. Expert Opin Ther Pat. 2005;15:153–66.\nNielsen CU, Andersen R, Brodin B, Frokjaer S, Taub ME, Steffansen B. Dipeptide model prodrugs for the intestinal oligopeptide transporter. Affinity for and transport via hPepT1 in the human intestinal Caco-2 cell line. J Control Release. 2001;76:129–38.\nJung D, Dorr A. Single-dose pharmacokinetics of valganciclovir in HIV- and CMV-seropositive subjects. J Clin Pharmacol. 1999;39:800–4.\nBailey PD, Boyd CA, Collier ID, George JP, Kellett GL, Meredith D, Morgan KM, Pettecrew R, Price RA. Affinity prediction for substrates of the peptide transporter PepT1. Chem Commun (Cambridge, UK) 2006;323–5\nBiegel A, Gebauer S, Hartrodt B, Brandsch M, Neubert K, Thondorf I. Three-dimensional quantitative structure-activity relationship analyses of beta-lactam antibiotics and tripeptides as substrates of the mammalian H+\u002Fpeptide cotransporter PEPT1. J Med Chem. 2005;48:4410–9.\nGebauer S, Knutter I, Hartrodt B, Brandsch M, Neubert K, Thondorf I. Three-dimensional quantitative structure–activity relationship analyses of peptide substrates of the mammalian H+\u002Fpeptide cotransporter PEPT1. J Med Chem. 2003;46:5725–34.\nAndersen R, Jorgensen FS, Olsen L, Vabeno J, Thorn K, Nielsen CU et al. Development of a QSAR model for binding of tripeptides and tripeptidomimetics to the human intestinal di-\u002Ftripeptide transporter hPEPT1. Pharm Res. 2006;23:483–92.\nLarsen SB, Jorgensen FS, Olsen L. QSAR models for the human H(+)\u002Fpeptide symporter, hPEPT1: affinity prediction using alignment-independent descriptors. J Chem Inf Model. 2008;48:233–41.\nMeredith D, Boyd CA, Bronk JR, Bailey PD, Morgan KM, Collier ID et al. 4-Aminomethylbenzoic acid is a non-translocated competitive inhibitor of the epithelial peptide transporter PepT1. J Physiol. 1998;512(Pt 3):629–34.\nEriksson AH, Elm PL, Begtrup M, Brodin B, Nielsen R, Steffansen B. Pyrimidine and nucleoside gamma-esters of L-Glu-Sar: synthesis, stability and interaction with hPEPT1. Eur J Pharm Sci. 2005;25:145–54.\nThomsen AE, Christensen MS, Bagger MA, Steffansen B. Acyclovir prodrug for the intestinal di\u002Ftri-peptide transporter PEPT1: comparison of in vivo bioavailability in rats and transport in Caco-2 cells. Eur J Pharm Sci. 2004;23:319–25.\nKnutter I, Theis S, Hartrodt B, Born I, Brandsch M, Daniel H et al. A novel inhibitor of the mammalian peptide transporter PEPT1. Biochemistry. 2001;40:4454–8.\nVig BS, Stouch TR, Timoszyk JK, Quan Y, Wall DA, Smith RL et al. Human PEPT1 pharmacophore distinguishes between dipeptide transport and binding. J Med Chem. 2006;49:3636–44.\nHerrera-Ruiz D, Faria TN, Bhardwaj RK, Timoszyk J, Gudmundsson OS, Moench P et al. A novel hPepT1 stably transfected cell line: establishing a correlation between expression and function. Mol Pharm. 2004;1:136–44.\nCruciani G, Pastor M, Guba W. VolSurf: a new tool for the pharmacokinetic optimization of lead compounds. Eur J Pharm Sci. 2000;11 Suppl 2:S29–39.\nCruciani G, Crivori P, Carrupt P-A, Testa B. Molecular fields in quantitative structure–permeation relationships: the VolSurf approach. J Mol Struct Theochem. 2000;503:17–30.\nVolsurf manual (VolSurf 4.1.4) (2008) In Molecular Discovery Ltd, Pinner\nCheng Y, Prusoff WH. Relationship between the inhibition constant (K1) and the concentration of inhibitor which causes 50 per cent inhibition (I50) of an enzymatic reaction. Biochem Pharmacol. 1973;22:3099–108.\nBrandsch M, Knutter I, Thunecke F, Hartrodt B, Born I, Borner V et al. Decisive structural determinants for the interaction of proline derivatives with the intestinal H+\u002Fpeptide symporter. Eur J Biochem. 1999;266:502–8.\nPedretti A, De LL, Marconi C, Negrisoli G, Aldini G, Vistoli G. Modeling of the intestinal peptide transporter hPepT1 and analysis of its transport capacities by docking and pharmacophore mapping. ChemMedChem. 2008;3:1913–21.\nEriksson L, Johansson E, Kettaneh-Wold N, Trygg J, Wikström C, Wold S. Multi- and megavariate data analysis, part I. Umeå: Umetrics; 2006.\nBrandsch M. Transport of drugs by proton-coupled peptide transporters: pearls and pitfalls. Expert Opin Drug Metab Toxicol. 2009;5:887–905.\nBiegel A, Knutter I, Hartrodt B, Gebauer S, Theis S, Luckner P et al. The renal type H+\u002Fpeptide symporter PEPT2: structure–affinity relationships. Amino Acids. 2006;31:137–56.\nSala-Rabanal M, Loo DD, Hirayama BA, Turk E, Wright EM. Molecular interactions between dipeptides, drugs and the human intestinal H+-oligopeptide cotransporter hPEPT1. J Physiol. 2006;574:149–66.\nBrandsch M, Ganapathy V, Leibach FH. H(+)-peptide cotransport in Madin–Darby canine kidney cells: expression and calmodulin-dependent regulation. Am J Physiol Ren Physiol. 1995;268:F391–7.\nTerada T, Sawada K, Ito T, Saito H, Hashimoto Y, Inui KI. Functional expression of novel peptide transporter in renal basolateral membranes. Am J Physiol Ren Physiol. 2000;279:F851–7.\nEriksson L, Johansson E, Kettaneh-Wold N, Trygg J, Wikström C, Wold S. Multi- and megavariate data analysis, part II. Umeå: Umetrics; 2006.\nKrogsgaard-Larsen P, Liljefors T, Madsen U. Textbook of drug design and discovery. London: Taylor & Francis; 2002.\nDalmasso G, Charrier-Hisamuddin L, Thu Nguyen HT, Yan Y, Sitaraman S, Merlin D. PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation. 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May 15th–17th, 2017, the US FDA and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) held a workshop at the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), to discuss the role of dissolution testing and translational modeling and simulation in enabling patient-centric solid oral drug product development. This 3-day event was attended by scientists from regulatory agencies, pharmaceutical companies, and academia. The workshop included podium presentations followed by breakout session discussions. The first day of the meeting focused on the challenges in dissolution method development and the role of dissolution testing throughout drug product development. On the second day, approaches to establish a link between in vitro testing and in vivo drug product performance (e.g., systemic exposure) were presented. Overall success rates and challenges in establishing IVIVCs via traditional and modern physiologically based pharmacokinetic (PBPK) modeling and simulation approaches were discussed. Day 3 provided an opportunity to discuss the expectations for establishing clinically relevant drug product specifications (CRDPS). It was recognized that understanding the impact of formulation and process variations on dissolution and in vivo performance is critical for most drug products formulated with poorly soluble drugs to ensure consistent product performance. The breakout sessions served as platforms for discussing controversial topics such as the clarification of dissolution terminology, PBPK model development and validation expectations, and approaches to set CRDPS. The meeting concluded with a commitment to continue the dialog between regulators, industry, and academia to advance overall product quality understanding.",{"EN":2162},"Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report",{"VOID":2164},"Miksinski SP. New drug applications: the evolution of quality review, in 2nd FDA\u002FPQRI Conference on advancing product quality. 2015: Bethesda, MD.\nSelen A, Dickinson PA, Müllertz A, Crison JR, Mistry HB, Cruañes MT, et al. The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance. J Pharm Sci. 2014;103(11):3377–97.\nUnited States Pharmacopeia and the National Formulary (USP-NF). Chapter 711 in US Pharmacopeial Convention. 2015. Rockville, MD.\nTakeuchi S, Tsume Y, Amidon GE, Amidon GL. Evaluation of a three compartment in vitro gastrointestinal simulator dissolution apparatus to predict in vivo dissolution. J Pharm Sci. 2014;103(11):3416–22.\nU.S. Department of Health and Human Services—Food and Drug Administration, CDER., Guidance for industry—dissolution testing of immediate release solid oral dosage forms. 1997.\nU.S. Department of Health and Human Services—Food and Drug Administration, CDER. Guidance for industry-extended release oral dosage forms: development, evaluation and application of in vitro\u002Fin vivo correlations. 1997.\nMiksinski SP. Clinical relevance—seeing the big picture, in dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nJu R, Grady H. Industry perspective on the current status and future of dissolution testing for product development and quality control, In Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nKuiper J, Coutant C. Use of bio-predictive methods during early formulation screening with case studies, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nLu X, J.-H. Han, and D. Mattocks, Dissolution methodologies from biorelevant to quality control: Challenges and gaps, in dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nZhang L, Hermans A The use of surrogates for dissolution testing for IR formulations: when is it feasible?, in Dissolution and Translational Modeling Strategies enabling Patient-Centric Product Development. 2017: Baltimore, MD.\nLi H, Prichard J, Swinney KA. Dissolution modeling for real time release testing (RTRT), in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nDrazer G, et al. Enabling real time release testing (RTRt) with NIR-based prediction of dissolution for tablets made by continuous direct compression (CDC), in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nSeo P. Challenges and strategies in establishing an in-vitro in-vivo link, in dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nMontague TH. Novel approaches in human PK study design (e.g. stable isotopes technique) to overcome the challenges in the conduct of dedicated BA\u002FBE studies (case studies), in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nSuarez-Sharp S, Li M, Duan J, Shah H, Seo P. Regulatory experience with in-vivo in-vitro correlations (IVIVC) in new drug applications. AAPS J. 2016;18(6):1379–90.\nVan Buskirk GA, Shah V. PQRI workshop report: application of IVIVC in formulation development. Dissolut Technol. 2014;21(2):51–8.\nMaziar K. Application of stochastic deconvolution in IVIVC development, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nNordmark A. EMA draft guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) Modelling and simulation, in dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nHuang W, Sau LL, Yu LX. Mechanistic approached to predicting oral drug absorption. AAPS J. 2009;11(2):217–24.\nKostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, et al. PBPK models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci. 2014;57:300–21.\nOlivares-Morales A, Parrott N, Stillhart C. Case studies of mechanistic absorption modeling and IVIVC, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nHolmstock N. Development of canagliflozin: mechanistic absorption modeling during late-stage formulation and process optimization: mechanistic absorption modeling during late-stage formulation and process optimization in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nPepin XJH, Flanagan TR, Holt DJ, Eidelman A, Treacy D, Rowlings CE. Justification of drug product dissolution rate and drug substance particle size specifications based on absorption PBPK modeling for Lesinurad immediate release tablets. Mol Pharm. 2016;13(9):3256–69.\nLin H-P. The utility of in silico PBPK absorption modeling and simulation as a tool to increase the success of developing bio-predictive dissolution methods: success and limitations (case studies from regulatory perspective), in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nZhao L, Tsakalozou E. The utility of in silico PBPK absorption modeling and simulation as a tool to develop bio-predictive dissolution methods, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nLi M, Zhao P, Pan Y, Wagner C. Predictive performance of physiologically based pharmacokinetic models for the effect of food on oral drug absorption: current status. CPT Pharmacometrics Syst Pharmacol. 2017;7(2):82–9.\nHeimbach T, He H. PBPK modeling and simulations of oral drug absorption\u002Ffood effect\u002FPPI \u002FPBIVIVC: opportunities and challenges, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nEinolf HJ, Lin W, Won CS, Wang L, Gu H, Chun DY, et al. Physiologically based pharmacokinetic model predictions of panobinostat (LBH589) as a victim and perpetrator of drug-drug interactions. Drug Metab Dispos. 2017;45(12):1304–16.\nLi M. Biorelevant dissolution testing for in vitro in vivo correlation\u002Frelationship (IVIVC\u002FR) development: regulatory perspective, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nSuarez-Sharp S. Paving the road towards setting clinically relevant specifications: biopharmaceutics perspectives on information needed, approach, and Criteria, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nKotzagiorgis E. Framework of setting clinically relevant specifications: approach, information needed, and criteria in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nAbend A. Framework for setting clinically relevant dissolution specifications (CRS), in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nHermans A, Abend AM, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, et al. Approaches for establishing clinically relevant dissolution specifications during drug development. AAPS J. 2017;19(6):1537–49.\nCohen M. The role of bio-predictive dissolution methods in the selection of CMAs, CPPS, and verification of design space (S): case studies, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nKesisoglou F. The utility of on level C IVIVC for setting clinically relevant specifications: case studies and implications, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nDavit B. Case study: use of in vivo pharmacokinetic data to develop a crs for in vitro dissolution testing, in Dissolution and translational modeling strategies enabling patient-centric product development. 2017: Baltimore, MD.\nMarroum P Establishing clinically relevant specifications during product life cycle: case studies in Dissolution and Translational Modeling Strategies enabling Patient-Centric Product Development. 2017: Baltimore, MD.\nEuropean Medicines Agency, Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and SIMULATION 2016.\nU.S. Department of Health and Human Services - Food and Drug Administration, CDER. Physiologically based pharmacokinetic analyses—format and content; draft guidance for industry. 2016.",{"VOID":2166},"10.1208\u002Fs12248-018-0213-x","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1208\u002Fs12248-018-0213-x",[2169,2184,2199,2214,2227,2242],{"id":2170,"sortIndex":32,"researcher":28,"roles":2171,"affiliations":2172,"properties":2181,"displayName":2183,"givenName":28,"familyName":28},"05c45b9f-c189-47ba-aa14-72e546df53cd",[1005],[2173],{"id":2174,"sortIndex":32,"affiliation":2175,"properties":28},"23c8177d-c747-48cc-8921-7a72f2b9b3dc",{"id":2174,"createTime":28,"updateTime":28,"relativeEntities":2176,"slug":28,"properties":2177,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2180,"statistic":28},[],{"title":2178},{"VI":2179},"Pharmaceutical Sciences, Merck, West Point, USA",[],{"title":2182},{"VI":2183},"Andreas 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Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group.N Engl J Med. 2000;343:246–253.",{"id":28,"text":2577,"url":28,"identifiers":28},"Nesiritide. Center for Drug Evaluation and Research, United States Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda.gov\u002Fohrms\u002Fdockets\u002Fac\u002Fcder99t.htm#Cardiovascular%20and% 20Renal%20Drugs\u002F3490t2.pdf. Accessed on March 21, 2005.",{"id":28,"text":2579,"url":28,"identifiers":28},"Publication Committee for the VMAC Investigators. Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial.JAMA. 2002;287:1531–1540.",{"id":28,"text":2581,"url":28,"identifiers":28},"Apomorphine, Center for Drug Evaluation and Research, US Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda.gov\u002Fcder\u002Ffoi\u002Fnda\u002F2004\u002F21-264_Apokyn.htm Accessed on March 21, 2005.",{"id":28,"text":2583,"url":28,"identifiers":28},"Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid.N Engl J Med. 2003;349:1676–1679.",{"id":28,"text":2585,"url":28,"identifiers":28},"Booth B, Rahman A, Ibrahim A, et al. A population pharmacokinetic model for zoledronic acid (ZOMETA) in patients with bone metastases.Am Soc Clin Pharmacol Ther. 2003;(PIII–20):67.",{"id":28,"text":2587,"url":28,"identifiers":28},"Zoledronic Acid Label: Center for Drug Evaluation and Research, US Food and Drug Administration. Available at: www.fda.gov\u002Fcder\u002Ffoi\u002Flabel\u002F2005\u002F021223s009.0101bl.pdf. Accessed March 21, 2005.",{"id":28,"text":2589,"url":28,"identifiers":28},"Zometa (Zoledronic Acid): Center for Drug Evaluation and Research, US, Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda\u002Fgov\u002Fmedwatch\u002FSAFETY\u002F2005\u002Fsafety05.htm#Zometa. Accessed March 29, 2005.",{"id":28,"text":2591,"url":28,"identifiers":28},"Busulfan, Center for Drug Evaluation and Research, United States Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda.gov\u002Fcder\u002Ffoi\u002Fnda\u002F2002\u002F20-954S004_Busulfex.htm Accessed March 21, 2005.",{"id":28,"text":2593,"url":28,"identifiers":28},"Slattery JT, Clift RA, Buckner CD, et al. Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation.Blood. 1997;89:3055–3060.",{"id":28,"text":2595,"url":28,"identifiers":28},"Grochow LB, Jones RJ, Brundrett RB, et al. Pharmacokinetics of busulfan: correlation with veno-occlusive disease in patients undergoing bone marrow transplantation.Cancer Chemother Pharmacol 1989;25:55–61.",{"id":28,"text":2597,"url":28,"identifiers":28},"DeMagalhaes-Silverman M, Bloom EJ, Donnenberg A, et al. Toxicity of busulfan and cyclophosphamide (BU\u002FCY2) in patients with hematologic malignancies.Bone Marrow Transplant. 1996;17:329–333.",{"id":28,"text":2599,"url":28,"identifiers":28},"Betapace (Sotalol Hydrochloride). Center for Drug Evaluation and Research, United States Food and Drug Administration. Available at:http:\u002F\u002Fwww.fda.gov\u002Fcder\u002Ffoi\u002Fnda\u002F2001\u002F19-865s10_Betapace.htm. Accessed March 21, 2005.",{"id":28,"text":2601,"url":28,"identifiers":28},"Shi J, Ludden TM, Melikian AP, Gastonguay MR, Hinderling PH. Population pharmacokinetics and pharmacodynamics of sotalol in pediatric patients with supraventricular or ventricular tachyarrhythmia.J Pharmacokinet Pharmacodyn. 2001;28:555–575.",{"id":28,"text":2603,"url":28,"identifiers":28},"Gobburu J. Could an, EOP2A meeting shorten drug development time? Available at: http:\u002F\u002Fwww.fda.gov\u002Fohrms\u002Fdockets\u002Fac\u002F03\u002Fslides\u002F 3998S1_06_Gobburu_files\u002Fframe.htm. Accessed March 21, 2005.",{"id":28,"text":2605,"url":28,"identifiers":28},"Kola I, Landis J. Can the pharmaceutical industry reduce, attrition rates?Nat Rev Drug Discov. 2004;3:711–715.",{"id":28,"text":2607,"url":28,"identifiers":28},"Advisory Committee for Pharmaceutical Science, Clinical Pharmacology Subcommittee, US Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda.gov\u002Fohrms\u002Fdockets\u002Fac\u002F03\u002Fslides\u002F 3998s1.htm. Accessed March 29, 2005.",{"id":28,"text":2609,"url":28,"identifiers":28},"Challenge and Oppurtunity on the Critical Path to New Medical Products, United States Food and Drug Administration. Available at: http:\u002F\u002Fwww.fda.gov\u002Foc\u002Finitiatives\u002Fcriticalpath\u002F. Accessed March 21, 2005.",{"id":2611,"createTime":2612,"updateTime":2612,"relativeEntities":2613,"slug":28,"properties":2614,"entityType":998,"verifyStatus":878,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":32,"primaryUrl":2623,"fullTextUrl":28,"authors":2624,"publicationType":1100,"publisherRelationship":2745,"citationCount":28,"citationInfo":28,"publishDate":2792,"publishYear":2793,"citationAnalyzeStatus":878,"lastCitationAnalyze":28,"indexDatabases":2794,"openAccess":28,"references":28,"isForceReanalyzing":1151},"02440dba-4d0d-444a-bd03-b1185ae8815e","2024-02-11T04:17:12.009+00:00",[],{"abstract":2615,"title":2617,"references":2619,"doi":2621},{"EN":2616},"The availability of reliable assays for measuring 4β-hydroxycholesterol (4β-HC), a CYP3A metabolite of cholesterol, is an important step in qualifying this endogenous moiety as a biomarker of CYP3A activity. Liquid and gas chromatographic methods with mass spectrometric detection have been developed with varying sensitivities, with or without derivatization. Care must be taken to chromatographically resolve 4β-HC from the multiple isobaric cholesterol oxidation products present in plasma, including 4α-hydroxycholesterol (4α-HC). Plasma concentrations of 4β-HC are low in humans (10–60 ng\u002Fml), lower than many other cholesterol metabolites and far less than cholesterol itself. Stability of 4β-HC has been established for at least 12 months at −20°C in plasma samples obtained with a typical clinical workflow. Oxidation of plasma cholesterol during storage produces both 4β-HC and 4α-HC, and 4α-HC may be used as assessment of sample quality. As 4β-HC concentrations over time in untreated individuals have low intra-individual variability, assay precision and reproducibility are the key assay attributes in assessing CYP3A4 induction, and potentially inhibition. Assessment of CYP3A4\u002F5 activity with 4β-HC relies on the differences between pre- and post-dose concentrations, in which each subject acts as their own control. To reduce analytical variability, samples from a single subject should be analyzed together to facilitate interpretation of study results. As an endogenous biomarker, 4β-HC offers the opportunity for less invasive assessment of CYP3A induction potential of new drugs during clinical development.",{"EN":2618},"Recommendations on the Development of a Bioanalytical Assay for 4β-Hydroxycholesterol, an Emerging Endogenous Biomarker of CYP3A Activity",{"VOID":2620},"Griffiths WJ, Hornshaw M, Woffendin G, Baker SF, Lockhart A, Heidelberger S, et al. Discovering oxysterols in plasma: a window on the metabolome. J Proteome Res. 2008;7(8):3602–12. doi:10.1021\u002Fpr8001639.\nDiczfalusy U, Nylén H, Elander P, Bertilsson L. 4β-Hydroxycholesterol, an endogenous marker of CYP3A4\u002F5 activity in humans. Br J Clin Pharmacol. 2011;71(2):183–9. doi:10.1111\u002Fj.1365-2125.2010.03773.x.\nGjestad C, Huynh DK, Haslemo T, Molden E. 4β-hydroxycholesterol correlates with dose but not steady-state concentration of carbamazepine: indication of intestinal CYP3A in biomarker formation? Br J Clin Pharm. 2016;81(2):269–76.\nBodin K, Bretillon L, Aden Y, Bertilsson L, Broomé U, Einarsson C, et al. Antiepileptic drugs increase plasma levels of 4β-hydroxycholesterol in humans: evidence for involvement of cytochrome P450 3A4. J Biol Chem. 2001;276(42):38685–9.\nSchroepfer Jr GJ. Oxysterols: modulators of cholesterol metabolism and other processes. Physiol Rev. 2000;80(1):361–554.\nBodin K, Andersson U, Rystedt E, Ellis E, Norlin M, Pikuleva I, et al. Metabolism of 4 beta-hydroxycholesterol in humans. J Biol Chem. 2002;277(35):31534–40.\nWide K, Larsson H, Bertilsson L, Diczfalusy U. Time course of the increase in 4beta-hydroxycholesterol concentration during carbamazepine treatment of paediatric patients with epilepsy. Br J Clin Pharmacol. 2008;65(5):708–15. doi:10.1111\u002Fj.1365-2125.2007.03078.x.\nDiczfalusy U, Kanebratt KP, Bredberg E, Andersson TB, Böttiger Y, Bertilsson L. 4beta-hydroxycholesterol as an endogenous marker for CYP3A4\u002F5 activity. Stability and half-life of elimination after induction with rifampicin. Br J Clin Pharmacol. 2009;67(1):38–43. doi:10.1111\u002Fj.1365-2125.2008.03309.\nKanebratt KP, Diczfalusy U, Bäckström T, Sparve E, Bredberg E, Böttiger Y, et al. Cytochrome P450 induction by rifampicin in healthy subjects: determination using the Karolinska cocktail and the endogenous CYP3A4 marker 4beta-hydroxycholesterol. Clin Pharmacol Ther. 2008;84(5):589–94. doi:10.1038\u002Fclpt.2008.132.\nHabtewold A, Amogne W, Makonnen E, Yimer G, Nylén H, Riedel KD, et al. 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J Clin Invest. 2002;110(6):725–30.",{"VOID":2622},"10.1208\u002Fs12248-016-9949-3","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1208\u002Fs12248-016-9949-3",[2625,2640,2655,2670,2685,2700,2715,2730],{"id":2626,"sortIndex":32,"researcher":28,"roles":2627,"affiliations":2628,"properties":2637,"displayName":2639,"givenName":28,"familyName":28},"d79de2bc-7085-4d61-94ba-ff46aeedb9f4",[1005],[2629],{"id":2630,"sortIndex":32,"affiliation":2631,"properties":28},"49a65440-1f7c-42d7-a436-6569a6c75983",{"id":2630,"createTime":28,"updateTime":28,"relativeEntities":2632,"slug":28,"properties":2633,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2636,"statistic":28},[],{"title":2634},{"VI":2635},"Bristol-Myers Squibb Co, Analytical and Bioanalytical Operations, Princeton, USA",[],{"title":2638},{"VI":2639},"Anne-Françoise Aubry",{"id":2641,"sortIndex":40,"researcher":28,"roles":2642,"affiliations":2643,"properties":2652,"displayName":2654,"givenName":28,"familyName":28},"0c8beac6-f18b-47ce-b128-2a307a59f0a3",[1005],[2644],{"id":2645,"sortIndex":32,"affiliation":2646,"properties":28},"5356e451-fae2-4e56-aafc-2dba36b87ede",{"id":2645,"createTime":28,"updateTime":28,"relativeEntities":2647,"slug":28,"properties":2648,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2651,"statistic":28},[],{"title":2649},{"VI":2650},"Genentech, Drug Metabolism and Pharmacokinetics, South San Francisco, USA",[],{"title":2653},{"VI":2654},"Brian Dean",{"id":2656,"sortIndex":123,"researcher":28,"roles":2657,"affiliations":2658,"properties":2667,"displayName":2669,"givenName":28,"familyName":28},"fa39813c-50ca-40c4-aa24-684b66bb863d",[1005],[2659],{"id":2660,"sortIndex":32,"affiliation":2661,"properties":28},"16d93459-2719-42e2-87d8-4d8d6c9e0ca9",{"id":2660,"createTime":28,"updateTime":28,"relativeEntities":2662,"slug":28,"properties":2663,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2666,"statistic":28},[],{"title":2664},{"VI":2665},"Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden",[],{"title":2668},{"VI":2669},"Ulf Diczfalusy",{"id":2671,"sortIndex":42,"researcher":28,"roles":2672,"affiliations":2673,"properties":2682,"displayName":2684,"givenName":28,"familyName":28},"194a73f9-7559-4d93-aa7f-9077d8ca6b0f",[1005],[2674],{"id":2675,"sortIndex":32,"affiliation":2676,"properties":28},"8ad0c498-ba9b-4592-8b77-c73bec8ba2fb",{"id":2675,"createTime":28,"updateTime":28,"relativeEntities":2677,"slug":28,"properties":2678,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2681,"statistic":28},[],{"title":2679},{"VI":2680},"Technical Operations, Amicus Therapeutics, Cranbury, USA",[],{"title":2683},{"VI":2684},"Angela Goodenough",{"id":2686,"sortIndex":45,"researcher":28,"roles":2687,"affiliations":2688,"properties":2697,"displayName":2699,"givenName":28,"familyName":28},"5c4b2f61-9524-4d2f-b9c2-8078d5b62f92",[1005],[2689],{"id":2690,"sortIndex":32,"affiliation":2691,"properties":28},"26b385f9-162c-498a-b417-be581513ec49",{"id":2690,"createTime":28,"updateTime":28,"relativeEntities":2692,"slug":28,"properties":2693,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2696,"statistic":28},[],{"title":2694},{"VI":2695},"Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Boston, USA",[],{"title":2698},{"VI":2699},"André Iffland",{"id":2701,"sortIndex":46,"researcher":28,"roles":2702,"affiliations":2703,"properties":2712,"displayName":2714,"givenName":28,"familyName":28},"5c357bcf-f3a7-44f9-b024-2a5e61158b02",[1005],[2704],{"id":2705,"sortIndex":32,"affiliation":2706,"properties":28},"015745fe-6e8e-483c-9524-b65d06b20a55",{"id":2705,"createTime":28,"updateTime":28,"relativeEntities":2707,"slug":28,"properties":2708,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2711,"statistic":28},[],{"title":2709},{"VI":2710},"Drug Development, Galleon Pharmaceuticals, Horsham, USA",[],{"title":2713},{"VI":2714},"James McLeod",{"id":2716,"sortIndex":48,"researcher":28,"roles":2717,"affiliations":2718,"properties":2727,"displayName":2729,"givenName":28,"familyName":28},"d343e30f-887a-4af9-8a7c-618f76bbabf1",[1005],[2719],{"id":2720,"sortIndex":32,"affiliation":2721,"properties":28},"4ffdcc33-5102-4da7-9930-e70cdbde53f3",{"id":2720,"createTime":28,"updateTime":28,"relativeEntities":2722,"slug":28,"properties":2723,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2726,"statistic":28},[],{"title":2724},{"VI":2725},"Pharmacokinetics, Pharmacodynamics and Metabolism, Janssen Research & Development, Spring House, USA",[],{"title":2728},{"VI":2729},"Naidong Weng",{"id":2731,"sortIndex":49,"researcher":28,"roles":2732,"affiliations":2733,"properties":2742,"displayName":2744,"givenName":28,"familyName":28},"56cb4660-8fe3-498c-9a63-300a5235f83d",[1005],[2734],{"id":2735,"sortIndex":32,"affiliation":2736,"properties":28},"bab4009f-954f-4f66-ada8-fb467be3e170",{"id":2735,"createTime":28,"updateTime":28,"relativeEntities":2737,"slug":28,"properties":2738,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2741,"statistic":28},[],{"title":2739},{"VI":2740},"Drug Metabolism and Pharmacokinetics, Novartis, East Hanover, USA",[],{"title":2743},{"VI":2744},"Ziping Yang",{"url":2623,"publisher":2746,"properties":2787},{"id":868,"createTime":869,"updateTime":870,"relativeEntities":2747,"slug":872,"properties":2748,"entityType":25,"verifyStatus":878,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":32,"subjectFields":2751,"manageAffiliations":2756,"indexDatabases":2767,"url":28,"thumbnailPath":28,"statistic":2782,"gsStatistic":28,"type":28,"analyzePriority":28},[],{"title":2749,"eissn":2750},{"EN":875},{"VOID":877},[2752],{"id":881,"createTime":28,"updateTime":28,"relativeEntities":2753,"label":2754,"description":2755,"parentId":28,"standard":28,"scholarHubFieldId":28},[],{"EN":884},{},[2757,2762],{"id":888,"createTime":28,"updateTime":28,"relativeEntities":2758,"slug":28,"properties":2759,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2761,"statistic":28},[],{"title":2760},{"EN":892},[894],{"id":896,"createTime":28,"updateTime":28,"relativeEntities":2763,"slug":28,"properties":2764,"entityType":28,"verifyStatus":28,"verifyTime":28,"verifyNote":28,"languages":28,"translateLanguages":28,"viewCount":28,"url":28,"parentIds":2766,"statistic":28},[],{"title":2765},{"EN":900},[],[2768,2775],{"id":904,"indexDatabase":2769,"url":916,"indexYears":28,"academicFieldIds":2774,"indexDatabaseRanking":28},{"id":906,"createTime":28,"updateTime":28,"relativeEntities":2770,"label":2771,"description":2772,"key":913,"publicationTags":2773,"standard":28},[],{"EN":909,"VI":909},{"EN":911,"VI":912},[915,813],[918],{"id":920,"indexDatabase":2776,"url":926,"indexYears":927,"academicFieldIds":2781,"indexDatabaseRanking":930},{"id":775,"createTime":28,"updateTime":28,"relativeEntities":2777,"label":2778,"description":2779,"key":781,"publicationTags":2780,"standard":28},[],{"EN":778,"VI":778},{"EN":778,"VI":780},[783],[929],{"impactFactor":32,"impactFactorByYear":2783,"i10Index":937,"i10IndexLast5Year":136,"totalPublication":938,"totalPublicationByYear":2784,"totalCitation":943,"totalCitationByYear":2785,"totalCitationPerPublication":959,"totalCitationPerPublicationByYear":2786,"hindexLast5Year":160,"hindex":160},{"2007":107,"2008":108,"2012":287,"2013":933,"2014":226,"2015":173,"2016":367,"2017":691,"2018":225,"2019":934,"2020":935,"2021":936,"2022":284,"2023":221},{"2004":126,"2005":567,"2006":567,"2007":140,"2008":689,"2009":157,"2010":280,"2011":50,"2012":329,"2013":428,"2014":154,"2015":940,"2016":941,"2017":942,"2018":611,"2019":158,"2020":358,"2021":560,"2022":611,"2023":200,"2024":127},{"2004":945,"2005":946,"2006":947,"2007":948,"2008":949,"2009":950,"2010":951,"2011":952,"2012":953,"2013":954,"2014":955,"2015":956,"2016":957,"2017":955,"2018":41,"2019":958,"2020":945,"2021":161,"2022":516},{"2004":961,"2005":962,"2006":963,"2007":964,"2008":965,"2009":966,"2010":967,"2011":968,"2012":969,"2013":970,"2014":971,"2015":972,"2016":973,"2017":974,"2018":975,"2019":976,"2020":977,"2021":978,"2022":173},{"pages":2788,"volume":2790},{"VOID":2789},"1056-1066",{"VOID":2791},"18","2016-06-27",2016,[915,930],{"id":2796,"createTime":2797,"updateTime":2798,"relativeEntities":2799,"slug":2800,"properties":2801,"entityType":998,"verifyStatus":26,"verifyTime":2798,"verifyNote":999,"languages":28,"translateLanguages":28,"viewCount":32,"primaryUrl":2810,"fullTextUrl":28,"authors":2811,"publicationType":1100,"publisherRelationship":2827,"citationCount":28,"citationInfo":28,"publishDate":2874,"publishYear":2875,"citationAnalyzeStatus":878,"lastCitationAnalyze":28,"indexDatabases":2876,"openAccess":28,"references":28,"isForceReanalyzing":1151},"02a6964d-beeb-4d61-874e-fdaa5eb6ee0e","2023-12-04T13:12:16.760+00:00","2024-12-12T07:54:50.605+00:00",[],"Computational-methods-in-drug-design-Modeling-G-protein-coupled-receptor-monomers-dimers-and-oligomers",{"abstract":2802,"title":2804,"references":2806,"doi":2808},{"EN":2803},"G protein-coupled receptors (GPCRs) are membrane proteins that serve as very important links through which cellular signal transduction mechanisms are activated. Many vital physiological events such as sensory perception, immune defense, cell communication, chemotaxis, and neuro-transmission are mediated by GPCRs. Not surprisingly, GPCRs are major targets for drug development today. Most modeling studies in the GPCR field have focused upon the creation of a model of a single GPCR (ie, a GPCR monomer) based upon the crystal structure of the Class A GPCR, rhodopsin. However, the emerging concept of GPCR dimerization has challenged our notions of the monomeric GPCR as functional unit. Recent work has shown not only that many GPCRs exist as homo- and heterodimers but also that GPCR oligomeric assembly may have important functional roles. This review focuses first on methodology for the creation of monomeric GPCR models. Special emphasis is given to the identification of localized regions where the structure of a GPCR may diverge from that of bovine rhodopsin. 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