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

Published 2015 View Full Article

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Title
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
Authors
Keywords
bioequivalence, emerging markets, generics, pMDIs and DPIs, regulatory requirements
Journal
AAPS Journal
Volume 17, Issue 5, Pages 1285-1304
Publisher
American Association of Pharmaceutical Scientists (AAPS)
Online
2015-05-23
DOI
10.1208/s12248-015-9787-8

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