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The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) is hosting a virtual public workshop entitled “In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions.”

The workshop will run Wednesday, August 18 through Friday August 20, 2021. It is free and open to the public, but registration is required.

Topics include study designs in different contexts; scale-up and post-approval changes; demonstration of bioequivalence for topical generics; heat effects for topical or transdermal delivery systems; bioavailability for sunscreen products; challenges with aberrant data, outliers, and inclusion/exclusion criteria; statistical analysis of IVPT data; theoretical principles and practical challenges with IVRT and IVPT method development, validation, and transfer; operational principles and practical challenges for IVRT and IVPT diffusion cell apparatus; submission of IVRT and IVPT information in ANDAs, including reportable information, format of data/results, organization of information, and common deficiencies; quality management systems, retention samples, laboratory qualification, documentation, and inspections for IVRT and IVPT studies submitted in ANDAs.

For additional information please contact the event organizers at complexgenerics@rx.umaryland.edu.



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