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Strategies of Bringing Drug Product Marketing Applications to Meet Current Regulatory Standards

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspe...

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Bibliographic Details
Published in:AAPS PharmSciTech
Main Authors: Wu, Yan, Freed, Anita, Lavrich, David, Raghavachari, Ramesh, Huynh-Ba, Kim, Shah, Ketan, Alasandro, Mark
Format: Artigo
Language:Inglês
Published: Springer US 2015
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Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4508294/
https://ncbi.nlm.nih.gov/pubmed/26024722
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-015-0334-9
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