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Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies

This article evaluates the performance of pharmacokinetic (PK) equivalence testing between two formulations of a drug through the Two-One Sided Tests (TOST) by a model-based approach (MB-TOST), as an alternative to the classical non-compartmental approach (NCA-TOST), for a sparse design with a few t...

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Detalles Bibliográficos
Autores principales:	Guhl, Mélanie, Mercier, François, Hofmann, Carsten, Sharan, Satish, Donnelly, Mark, Feng, Kairui, Sun, Wanjie, Sun, Guoying, Grosser, Stella, Zhao, Liang, Fang, Lanyan, Mentré, France, Comets, Emmanuelle, Bertrand, Julie
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer US 2022
Materias:	Original Paper
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9483500/ https://www.ncbi.nlm.nih.gov/pubmed/36112338 http://dx.doi.org/10.1007/s10928-022-09821-z

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