Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Highly variable (HV) drugs are defined as those for which within-subject variability (%CV) in bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to en...

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Detalhes bibliográficos
Main Authors: Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann, Donald J., Yu, Lawrence X.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2012
Assuntos:
Review Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3475857/
https://ncbi.nlm.nih.gov/pubmed/22972221
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-012-9406-x
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