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

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 [[Formula: see text]]) are obtained by noncompartmental analysis (NCA), and the BE analysis i...

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Detalles Bibliográficos
Autores principales: Tardivon, Coralie, Loingeville, Florence, Donnelly, Mark, Feng, Kairui, Sun, Wanjie, Sun, Guoying, Grosser, Stella, Zhao, Liang, Fang, Lanyan, Mentré, France, Bertrand, Julie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10349197/
https://www.ncbi.nlm.nih.gov/pubmed/37114321
http://dx.doi.org/10.1002/psp4.12960