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Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These drug products are locally applied and not intended for system...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Veröffentlicht in:AAPS J
Hauptverfasser: Braddy, April C., Davit, Barbara M., Stier, Ethan M., Conner, Dale P.
Format: Artigo
Sprache:Inglês
Veröffentlicht: Springer US 2014
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4287290/
https://ncbi.nlm.nih.gov/pubmed/25344440
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9679-3
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