Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies

• Main Authors: Coralie Tardivon (Author), Florence Loingeville (Author), Mark Donnelly (Author), Kairui Feng (Author), Wanjie Sun (Author), Guoying Sun (Author), Stella Grosser (Author), Liang Zhao (Author), Lanyan Fang (Author), France Mentré (Author), Julie Bertrand (Author)
• Format: Book
• Published: Wiley, 2023-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two‐way crossover study is conducted, PK parameters (namely the area under the time‐concentration curve [AUC] and the maximal concentration [Cmax]) are obtained by noncompartmental analysis (NCA), and the BE analysis is perf...