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Bioanalytical method validation: concepts, expectations and challenges in small molecule and macromolecule--a report

Edward D Bashaw1, Binodh DeSilva, Mark J Rose

  • 1Office of Clinical Pharmacology, Center for Drug Evaluations and Research, United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

The AAPS Journal
|April 5, 2014
PubMed

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