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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...

詳細記述

保存先:
書誌詳細
出版年:AAPS J
主要な著者: Braddy, April C., Davit, Barbara M., Stier, Ethan M., Conner, Dale P.
フォーマット: Artigo
言語:Inglês
出版事項: Springer US 2014
主題:
オンライン・アクセス: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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