Contraception Requirements in Early Clinical Trials: Considerations Towards an Evidence-Based Approach.

 0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Tatyana Dubich, Ad F Roffel

Ngôn ngữ: eng

Ký hiệu phân loại: 949.59012 *Greece

Thông tin xuất bản: New Zealand : Pharmaceutical medicine , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 551530

Enrollment of women of childbearing potential in clinical trials from early stages of drug development allows the gathering of relevant safety and pharmacokinetics data in the representative disease population. However, risk mitigation strategies are needed to ensure the safety of the developing embryo in case of unintended pregnancy in female study participants or in female partners of male study participants. These risk mitigation strategies often include contraception requirements, however we observed that such requirements vary widely across sponsors and trials. Some sponsors and contract research organizations adhere to the strictest precautions by default, assuming a worst-case scenario for each new compound's risk assessment. In this review, we provide an overview of the risks addressed by and introduced by contraception requirements in clinical trials. We critically discuss the 'worst-case' approach, and we present a holistic, risk-based approach that takes into account all relevant data, the pros and cons of using hormonal contraceptives, and subject burden.
Tạo bộ sưu tập với mã QR

THƯ VIỆN - TRƯỜNG ĐẠI HỌC CÔNG NGHỆ TP.HCM

ĐT: (028) 36225755 | Email: tt.thuvien@hutech.edu.vn

Copyright @2024 THƯ VIỆN HUTECH