March 17, 2015
On April 16, 2015, the U.S. Food and Drug Administration will sponsor a public meeting to discuss the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of non-systemically absorbed (locally acting) drug products intended for use in veterinary species. The meeting will be held at the FDA Center for Veterinary Medicine, 7519 Standish Place, Rockville, Maryland.
Given the imprecision and logistic challenges associated with clinical endpoint BE studies, the FDA is exploring alternative pathways that can be applied to ensure the equivalence of product performance and quality for those products that are non-systemically absorbed. Examples of the kinds of products where in vitro bioequivalence concepts can potentially be applied include some orally administered products (e.g., Type A medicated articles), solutions, emulsions, ointments, creams, suspensions, transdermal products, and intra-mammary formulations.
The FDA is seeking public input on current agency BE regulations and the possibility of adopting novel in vitro BE approaches based on in vitro release tests and product physico-chemical characterization. There will be opportunities for the speakers to respond to questions from the public as well an opportunity for participants to provide formal public comments. The agency encourages the public to submit comments and questions to the docket prior to the meeting.
Early registration is recommended because seating is limited. Attendees may register, ask general questions about the meeting, request an opportunity to make an oral presentation, or request special accommodations due to a disability by contacting Aleta Sindelar, CVM, FDA; 7519 Standish Place, Room 144, Rockville, MD 20855, 240-276-9230; Fax 240-276-9241; email address BioequivalencePublicMeetingRegistration@fda.hhs.gov.
A webcast of the meeting will also be available at https://collaboration.fda.gov/cvm_bioequivalence_meeting/.
Notice of Public Meeting: Identification of Alternative In Vitro Bioequivalence Pathways Public Meeting - Identification of Alternative In Vitro Bioequivalence (BE) Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals Regulations.gov
Submit public comments to Docket No. FDA-2015-N-0684