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International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused...

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Bibliografiske detaljer
Main Authors: Davit, Barbara, Braddy, April C., Conner, Dale P., Yu, Lawrence X.
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2013
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC3787230/
https://ncbi.nlm.nih.gov/pubmed/23821352
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9499-x
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