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...

Full beskrivning

Sparad:
Bibliografiska uppgifter
I publikationen:AAPS J
Huvudupphovsmän: 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
Materialtyp: Artigo
Språk:Inglês
Publicerad: Springer US 2015
Ämnen:
Meeting Report
Länkar: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
Taggar: Lägg till en tagg
Inga taggar, Lägg till första taggen!

Liknande verk