Location Details
The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD
Event Details
The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products, when utilizing efficient characterization-based bioequivalence approaches.
The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs. The focus will be on IVPT method procedures that abbreviated new drug application (ANDA) applicants frequently struggle to implement successfully, and the procedures will be demonstrated using different IVPT diffusion cell systems from major manufacturers. Critical considerations to guide investigators during method development, validation, and study conduct will be discussed at each stage. Also, best practices for dealing with issues that arise in different scenarios will be discussed.
Join us in person for an interactive experience featuring hands-on activities with diffusion cell systems from different manufacturers to discuss how different design features could impact how you implement FDA Guidance recommendations. Small group working sessions (only for in-person attendees) will simulate challenges and illustrate how one should navigate decisions during IVPT method development and study design for a hypothetical topical drug product. In person attendees will also have the chance to engage with regulatory, academic, and industry experts to ask questions, learn practical skills, share knowledge, and discuss how to approach challenges you may have experienced with IVPT studies. Virtual attendees will enjoy the convenience of accessing live presentations and panel sessions that discuss procedures illustrated with pre-recorded demonstrations.
- Theoretical/conceptual understanding of the recommendations in the IVPT guidance
- Demonstration of step-by-step procedures using 4 different diffusion cell systems
- Critical considerations for method development, validation, and study conduct
- Expert guidance and best practices for overcoming challenges
For more information, please visit the Center for Research on Complex Generics website.
