In Vitro Drug Release Testing for LA Drug Products QC (16of35) Complex Generics - Sep. 25-26, 2019

Vidula Kolhatkar, from CDER Office of Pharmaceutical Quality’s Division of Biopharmaceutics, discusses the current approach to in vitro release test (IVRT) to include product specific in vitro release test, discriminating ability, and acceptance criteria. She also shares common deficiencies and steps forward.

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


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