The Elm

This workshop will clarify the intent of FDA recommendations for in vitro permeation test (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 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.

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