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Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

Karen M. Alsante; Kim Huynh-Ba; Steven W. Baertschi; Robert A. Reed; Margaret S. Landis; Mark H. Kleinman; Christopher Foti; Venkatramana M. Rao; Paul Meers; Andreas Abend; Daniel W. Reynolds; Biren K. Joshi
AAPS PharmSciTech · Vol. 15, Issue 1 · pp. 198-212 · 2014
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Bibliographic Information

JournalAAPS PharmSciTech
PublisherSpringer
Publication Date2014-02-01
Publication Year2014
Volume15
Issue1
Pages198-212
Document TypeJournal Article
eISSN1530-9932
DOI10.1208/s12249-013-0047-x

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NARA Access Coverage2000-01-01~Current
Journal Homepagehttps://www.springer.com/journal/12249
Publisher PageOpen Publisher Page
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