Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal...

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Detalles Bibliográficos
Autores principales: do Carmo, Ana Cerúlia Moraes, Piras, Stefânia Schimaneski, Rocha, Nayrton Flávio Moura, Gratieri, Tais
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2017
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5322421/
https://www.ncbi.nlm.nih.gov/pubmed/28280742
http://dx.doi.org/10.1155/2017/7894937

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5322421/
https://www.ncbi.nlm.nih.gov/pubmed/28280742
http://dx.doi.org/10.1155/2017/7894937

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