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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...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Braddy, April C., Davit, Barbara M., Stier, Ethan M., Conner, Dale P.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2014
Assuntos:
Acesso em linha: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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