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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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Bibliografski detalji
Glavni autori: Davit, Barbara, Braddy, April C., Conner, Dale P., Yu, Lawrence X.
Format: Artigo
Jezik:Inglês
Izdano: Springer US 2013
Teme:
Online pristup: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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