Director US Food and Drug Administration Clarksburg
21 CFR Part 320 outlines bioavailability and bioequivalence (BE) requirements. In some instances, in vitro bioequivalence methods are used to demonstrate that a drug product is equivalent to a reference drug product in lieu of a human bioequivalence study using laboratory techniques like dissolution rate testing. The FDA publishes the requirements for in vitro bioequivalence methods in the Product Specific Guidances. This session is aimed at providing insights regarding how FDA assesses applications containing in vitro BE methods and how the agency inspects sites that perform perform theses tests with specific case studies.
Learning Objectives:
To describe the regulatory aspects and nuisances about in vitro bioequivalence testing from experts in the field.
The attendees will learn recent trends with specific studies discussed by experts from the FDA and industry.
The participants will be able to dialogue with experts regarding application submissions and get ready for inspections.
