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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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Detalles Bibliográficos
Publicado en:AAPS J
Main Authors: Soares, Kelen Carine Costa, Santos, Gustavo Mendes Lima, Gelfuso, Guilherme M., Gratieri, Tais
Formato: Artigo
Idioma:Inglês
Publicado: Springer US 2015
Assuntos:
Acceso en liña: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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