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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Pubblicato in:Transl Clin Pharmacol
Autori principali: Chung, Inbum, Oh, Jaeseong, Lee, SeungHwan, Jang, In-Jin, Lee, Youngjo, Chung, Jae-Yong
Natura: Artigo
Lingua:Inglês
Pubblicazione: Korean Society for Clinical Pharmacology and Therapeutics 2017
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Original Article
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC7033408/
https://ncbi.nlm.nih.gov/pubmed/32095472
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.12793/tcp.2017.25.4.179
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