Evaluation of model‐integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods

• Main Authors: Henrik Bjugård Nyberg (Author), Xiaomei Chen (Author), Mark Donnelly (Author), Lanyan Fang (Author), Liang Zhao (Author), Mats O. Karlsson (Author), Andrew C. Hooker (Author)
• Format: Book
• Published: Wiley, 2024-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Conventional approaches for establishing bioequivalence (BE) between test and reference formulations using non‐compartmental analysis (NCA) may demonstrate low power in pharmacokinetic (PK) studies with sparse sampling. In this case, model‐integrated evidence (MIE) approaches for BE assessm...