Bioanalytical Inspections: Overview and Case Studies – June 17, 2019

Drs. Seongeun Julia Cho and John Kadavil from CDER’s Division of Generic Drug Bioequivalence Evaluation and Office of Study Integrity and Surveillance discuss how FDA conducts analytical inspections of bioanalytical/bioequivalence studies. They also review how FDA evaluates inspectional findings, determines if analytical methods are validated, and analyte concentrations from study samples are accurate and precise to provide high quality data to support successful applications.

Learn more at https://www.fda.gov/drugs/cder-small-....
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