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Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Karen M. Alsante; Kim C. Huynh-Ba; Steven W. Baertschi; Robert A. Reed; Margaret S. Landis; Scott Furness; Bernard Olsen; Mark Mowery; Karen Russo; Robert Iser; Gregory A. Stephenson; Patrick Jansen
AAPS PharmSciTech · Vol. 15, Issue 1 · pp. 237-251 · 2014

Abstract

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Bibliographic Information

JournalAAPS PharmSciTech
PublisherSpringer
Publication Date2014-02-01
Publication Year2014
Volume15
Issue1
Pages237-251
Document TypeJournal Article
eISSN1530-9932
DOI10.1208/s12249-013-0061-z

Access Information

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