- August 18 - 20, 2021
- - ET
- - ET
- - ET
August 18 – 20, 2021
August 18: 8:30 a.m. – 5 p.m. ET
August 19: 8:30 a.m. – 4:15 p.m. ET
August 20: 9 a.m. – 5 p.m. ET
About the Event:
The U.S. Food and Drug Administration and the Center for Research on Complex Generics (CRCG) will host a free virtual public workshop on August 18-20, 2021, titled "In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions."
IVRT and IVPT are important methods used by the generic drug industry and in other contexts to support demonstrations of bioequivalence for generic topical drug products, evaluations of the heat effects and product quality for generic transdermal delivery systems (also known as patches), assessments of the bioavailability of ingredients in sunscreen products, and characterization of other biopharmaceutical aspects of topical and transdermal generic drug products.
The purpose of this workshop is to 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.
FDA and the CRCG — which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy — are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
- 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
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.
For More Information:
More information about this event, including an agenda, will be available on the CRCG event webpage soon.