Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points

• Main Authors: Xiaomei Chen (Author), Henrik B. Nyberg (Author), Mark Donnelly (Author), Liang Zhao (Author), Lanyan Fang (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 By applying nonlinear mixed‐effect (NLME) models, model‐integrated evidence (MIE) approaches are able to analyze bioequivalence (BE) data with pharmacokinetic end points that have sparse sampling, which is problematic for non‐compartmental analysis (NCA). However, MIE approaches may suffer...