Springer Science and Business Media LLC
Công bố khoa học tiêu biểu
* Dữ liệu chỉ mang tính chất tham khảo
Sắp xếp:
FDA Inspection of Investigator Sites in Italy
Springer Science and Business Media LLC - Tập 31 - Trang 187-191 - 1997
The United States Food and Drug Administration (FDA) conducts investigator site inspections both in the United States and foreign countries. This paper reports on the experience of an FDA inspection performed at two Italian centers producing data submitted to the FDA in support of a new drug application (NDA) for market approval. The inspection procedures outside the United States are the same as ...... hiện toàn bộ
Rationale for Drug Development of Herbals in Oncology: Clinical, Industry, and Regulatory Perspectives
Springer Science and Business Media LLC - Tập 33 Số 4 - Trang 1003-1010 - 1999
Compilation of Quantitative Overviews of Studies of Adherence
Springer Science and Business Media LLC - Tập 38 - Trang 197-210 - 2004
Purpose of Study. The purposes of this article are to: (1) Compile and critique quantitative reviews of studies of adherence with prescribed medications, and (2) Summarize current knowledge of adherence from the perspective of this literature.Methods. MEDLINE and other bibliographic databases were searched for quantitative reviews in which adherence with prescribed drugs was an endpoint. The revie...... hiện toàn bộ
Getting the Best from Freelance Writers
Springer Science and Business Media LLC - Tập 33 - Trang 663-667 - 1999
Contracting out can significantly relieve pressure on internal resources, but it can also be a time-consuming and frustrating activity. The success of contracting out is significantly enhanced by a planning stage to decide: why the job is being contracted out (time, expertise), what exactly is needed, who the writer should be, where the writer should be based, when the document is needed, and how ...... hiện toàn bộ
Regulatory Implications of Excipient Changes in Medicinal Products
Springer Science and Business Media LLC - Tập 34 - Trang 875-894 - 2000
Health authorities increasingly recognize the role excipients play as essential constituents of medicinal products. Pharmaceutical excipients contribute unique functionalities to formulations, thereby largely determining the drug product’s quality and influencing its safety and efficacy. Changes and variations of excipients in licensed products are, there-fore, placed under strict regulatory contr...... hiện toàn bộ
A Behavioral Bayes Method for Determining the Size of a Clinical Trial
Springer Science and Business Media LLC - Tập 34 Số 2 - Trang 355-363 - 2000
An Overview of Bridging Study Evaluation in Taiwan
Springer Science and Business Media LLC - Tập 43 - Trang 371-376 - 2009
In 2001, the Bridging Study Evaluation (BSE) review process based on the ICH E5 guideline was introduced in Taiwan. The purpose of BSE is to assess the impact of ethnic factors on a drug’s safety and efficacy and to determine whether pharmaceutical sponsors should conduct regional bridging studies in Taiwan. In this report, we provide the background and experience of BSE implementation in Taiwan a...... hiện toàn bộ
Shelf-Life Estimation for Multifactor Stability Studies
Springer Science and Business Media LLC - Tập 31 - Trang 573-587 - 1997
In stability analysis, the current Food and Drug Administration (FDA) recommended procedure for estimating the expiration dating period (shelf-life) of a drug is limited to a single package, single strength product. Since most drug products are manufactured with more than one strength and are marketed in more than one package, stability analyses must be carried out for every combination of package...... hiện toàn bộ
Đánh giá Dữ liệu từ Các thử nghiệm lâm sàng Có liên quan Chặt chẽ Dịch bởi AI
Springer Science and Business Media LLC - Tập 35 Số 4 - Trang 1317-1326 - 2001
Trong quá trình phát triển thuốc, các thử nghiệm lâm sàng được thực hiện cho các bệnh hoặc chỉ định khác nhau. Thông thường, việc đánh giá hiệu quả của thuốc chỉ dựa vào dữ liệu từ các thử nghiệm lâm sàng trong một chỉ định cụ thể. Tuy nhiên, trong một số trường hợp, các chỉ định khác nhau có mối liên hệ chặt chẽ với nhau. Chúng có thể tương tự về nguyên nhân học hoặc bệnh lý học. Ngay cả khi các ...... hiện toàn bộ
#thử nghiệm lâm sàng #hiệu quả thuốc #tổng hợp bằng chứng #chỉ định điều trị #phương pháp Bayes
Tổng số: 1,078
- 1
- 2
- 3
- 4
- 5
- 6
- 10