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A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies

Because bioequivalence studies are performed using a crossover design, information on the intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs based on bioequivalence results of identical generic drug...

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Detalles Bibliográficos
Autores principales: Chung, Inbum, Oh, Jaeseong, Lee, SeungHwan, Jang, In-Jin, Lee, Youngjo, Chung, Jae-Yong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society for Clinical Pharmacology and Therapeutics 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989220/
https://www.ncbi.nlm.nih.gov/pubmed/32055541
http://dx.doi.org/10.12793/tcp.2018.26.1.6