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BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements

The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for indust...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:AAPS J
Prif Awduron: Davit, Barbara M., Kanfer, Isadore, Tsang, Yu Chung, Cardot, Jean-Michel
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: Springer US 2016
Pynciau:
Mynediad Ar-lein:https://ncbi.nlm.nih.gov/pmc/articles/PMC5256598/
https://ncbi.nlm.nih.gov/pubmed/26943914
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9877-2
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