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An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the “Brazilian Health Surveillance Agency” (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (Decem...

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Bibliografiske detaljer
Udgivet i:AAPS J
Main Authors: Soares, Kelen Carine Costa, Santos, Gustavo Mendes Lima, Gelfuso, Guilherme M., Gratieri, Tais
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2015
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4627447/
https://ncbi.nlm.nih.gov/pubmed/26122498
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9801-1
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