Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Lee, Sau L., Saluja, Bhawana, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Li, Ying, Lu, Sarah, Hou, Shuguang, Rebello, Juliet, Vaidya, Abhijit, Gogtay, Jaideep, Purandare, Shrinivas, Lyapustina, Svetlana
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2015
Assuntos:
Meeting Report
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4540743/
https://ncbi.nlm.nih.gov/pubmed/26002510
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9787-8
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