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Development of a Control Strategy for Benzene Impurity in HPMCAS-Stabilized Spray-Dried Dispersion Drug Products Using a Science-Based and Risk-Based Approach

Hongfei Yue; Sarah J. Nicholson; Joel D. Young; Daniel Hsieh; Rodney J. Ketner; Robert G. Hall; Jeremy Sackett; Elizabeth C. Banks; John A. Castoro; Michael E. Randazzo
Pharmaceutical Research · 2015

Abstract

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Bibliographic Information

JournalPharmaceutical Research
PublisherSpringer
Publication Date2015-02-28
Publication Year2015
Document TypeJournal Article
Print ISSN0724-8741
eISSN1573-904X
DOI10.1007/s11095-015-1649-7

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NARA Access Coverage1984-01-01~Current
Journal Homepagehttps://www.springer.com/journal/11095
Publisher PageOpen Publisher Page
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