Registration Now Open for FDA Co-Hosted Workshop on In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . Registration Now Open for FDA Co-Hosted Workshop on In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions   This workshop is FREE. Registration and Agenda   ABOUT IVRT and IVPT are important methods used by the generic drug industry and in other contexts to support demonstrations of bioequivalence, evaluations of the heat effects and product quality, bioavailability assessments, and characterization of other biopharmaceutical aspects of topical and transdermal generic drug products. This public workshop will discuss the scientific principles and practical considerations that inform current FDA thinking and USP recommendations for IVRT and IVPT studies, explore challenging issues that would benefit from broader discussion, identify areas that would benefit from further research, and discuss opportunities for coordination and collaboration between the FDA, USP, academic institutions, product manufacturers, diffusion cell equipment manufacturers, contract research organizations, consultants and other stakeholders.   TOPICS IVRT study designs in different contexts including supporting a demonstration of bioequivalence for topical generics, scale-up and post-approval changes, and different dosage forms IVPT study designs in different contexts including supporting a demonstration of bioequivalence for topical generics, heat effects for topical or transdermal delivery systems, and bioavailability for sunscreen products Challenges with aberrant data, outliers, inclusion/exclusion criteria, and 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   AUDIENCE Generic drug industry stakeholders including scientists/researchers, clinicians, and regulatory affairs professionals who work on or are interested in the development of IVRT and IVPT studies.   This workshop is a co-sponsored event between FDA and the Center for Research on Complex Generics.   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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