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

Public Meeting & Request for Comments
April 16, 2015
Center for Veterinary Medicine
Office of Foods and Veterinary Medicine
Food and Drug Administration
7519 Standish Place
Conference Room A, 3rd Floor
Rockville, MD 20855
Docket No. FDA-2015-N-0684

AGENDA

8:30 AM - Registration

9:00 AM - Opening Remarks

9:10 AM - Importance of In Vitro Bioequivalence Pathways

9:20 AM - FDA/CVM Demonstrating Bioequivalence

9:40 AM - In Vitro Bioequivalence Pathways

10:20 AM - Break

10:40 AM - The Use of In Vitro Bioequivalence as a Regulatory Approach

11:20 AM - Open Public Comment Period

12:00 PM - Lunch

1:00 PM - Open Public Comment Period - Continued

2:00 PM - Question & Answers: Open Forum

3:30 PM - Break

3:45 PM - Meeting Summary & Next Steps

4:00 PM - ADJOURN