Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests (TOST).

• Tác giả: Gregory Campbell, Somesh Chattopadhyay, Kairui Feng, Meng Hu, Jae H Lee, Carl C Peck, Jing Wang, Liang Zhao
• Ngôn ngữ: eng
• Thông tin xuất bản: United States : The AAPS journal , 2025
• Bộ sưu tập: NCBI
• ID: 738314

Tóm tắt

The regulatory statistical standard for evaluating average bioequivalence (BE) in generic drug testing, formulation bridging, and 505b2 drug comparisons has traditionally employed the two one-sided t-tests (TOST) procedure. A comparison of BE determinations of TOST and a t-distribution-based, non-informative Bayesian procedure (Bayes