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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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| Опубликовано в: : | AAPS J |
|---|---|
| Главные авторы: | , , , |
| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
Springer US
2015
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| Предметы: | |
| Online-ссылка: | 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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