Nghiên cứu Mối quan hệ Liều-Lượng Thích ứng

Springer Science and Business Media LLC - Tập 40 - Trang 451-461 - 2006
Brenda Gaydos1, Michael Krams2, Inna Perevozskaya3, Frank Bretz4, Qing Liu5, Paul Gallo4, Don Berry6, Christy Chuang-Steln7, José Pinheiro4, Alun Bedding1
1Eli Lilly and Company, Lilly Corporate Center, Indianapolis, USA
2Wyeth, USA
3Merck, USA
4Novartis, USA
5Johnson & Johnson, USA
6M. D. Anderson Cancer Center, USA
7Pfizer, USA

Tóm tắt

Sự khám phá không đầy đủ về mối quan hệ liều-lượng là một điểm yếu trong phát triển thuốc lâm sàng, và việc không xác định liều lượng sớm thường được coi là một yếu tố quan trọng góp phần vào tỷ lệ thất thoát cao trong giai đoạn muộn mà hiện ngành công nghiệp đang phải đối mặt. Các phương pháp thích ứng, chẳng hạn như thiết kế một nghiên cứu thử nghiệm tính khả thi như một thử nghiệm mối quan hệ liều-lượng thích ứng. Việc học tập hiệu quả về mối quan hệ liều-lượng sớm hơn trong quá trình phát triển cuối cùng sẽ giảm thiểu chi phí tổng thể và cung cấp thông tin tốt hơn về liều trong gói nộp hồ sơ. Bài báo này trình bày những khuyến nghị chính của nhóm làm việc thuộc Hiệp hội Nghiên cứu Dược phẩm và Các Nhà sản xuất Hoa Kỳ về các nghiên cứu mối quan hệ liều-lượng thích ứng. Như phần nền tảng, các thiết kế mối quan hệ liều-lượng cố định và thích ứng truyền thống sẽ được xem xét ngắn gọn. Thông tin về việc phát triển thiết kế liều lượng thích ứng Bayesian và một số vấn đề theo dõi và xử lý cũng sẽ được thảo luận.

Từ khóa

#mối quan hệ liều-lượng; nghiên cứu thích ứng; phát triển thuốc; thiết kế thử nghiệm; nhóm làm việc; chiến lược thích ứng; thiết kế Bayesian

Tài liệu tham khảo

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