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...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Julkaisussa:AAPS J
Päätekijät: 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
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: Springer US 2015
Aiheet:
Meeting Report
Linkit: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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