Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.

Quantitative methods and modeling (QMM) are rapidly demonstrating their potential to support generic drug development and assessment. The session explored generic industry perspectives about the challenges impacting generic product development that are the most critical to address by GDUFA research initiatives during the next 5 years. MAIN TEXT On May 9 and 10, 2022, the US Food and Drug Administration (FDA) hosted the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiative Public Workshop as a commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II). [Extracted from the article]