Join FDA and the Center for Research on Complex Generics – a collaboration of the School of Pharmacy and the University of Michigan College of Pharmacy - for the Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches Workshop, Sept. 30 – Oct. 1. The purpose of this workshop is to engage the generic drug industry and other involved stakeholders regarding how mechanistic modeling and simulation can support their product development and regulatory submissions, share the current state of mechanistic modeling for BE assessment through case studies, establish a consensus on best practices for using PBPK and CFD modeling for BE assessment to help drive further investment by the generic drug industry into mechanistic modeling and simulation, and roll out the concept of a Model Master File to improve model-sharing between model developers, industry, and FDA. Topics that will be covered included:
- Mechanistic modeling of orally inhaled generic drug products
- Mechanistic modeling of dermal generic drug products
- Mechanistic modeling of other locally-acting generic drug products
- Oral PBPK as alternative BE approach
- Oral PBPK for evaluating the impact of food on BE
- Challenges and successful cases for oral PBPK
- Model acceptance and model sharing for regulatory use
The workshop is free. Click here for more information and registration.