Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms

Min Li, PhD, Acting Biopharmaceutics Lead for the Division of Biopharmaceutics, discusses the scientific and risk-based framework associated with the Agency’s evaluation of invitro dissolution method development for generic immediate-release, extended-release and delayed-release solid oral drug products.
Learn more at: https://www.fda.gov/drugs/news-events...
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