- October 27 - 28, 2022
- Thu, Oct 27
- Fri, Oct 28
About the Event:
Quantitative methods and modeling approaches have been increasingly utilized by the generic drug industry and regulatory agencies, including the FDA, to support generic product development and regulatory assessments. These quantitative methods and modeling involve mechanistic modeling such as physiologically based pharmacokinetic (PBPK) modeling and computational fluid dynamics (CFD) modeling, quantitative clinical pharmacology tool sets such as population pharmacokinetics (PPK) approaches, and advanced data analytics methodologies. Quantitative methods, modeling and simulation approaches are being utilized to support alternative bioequivalence (BE) approaches and to minimize the burden of (or even alleviate the need for) in vivo BE studies.
The purpose of this workshop is to discuss how to modernize approaches for efficiently demonstrating BE, to establish their role in modern paradigms of generic drug development, and to explore and develop best practices for the use of modeling and simulation approaches in regulatory submissions and approval. This workshop will engage experts from regulatory agencies, the generic drug industry, consultants, academia, and others in the field of modeling and simulation to discuss the opportunities and best practices for incorporating modeling and simulation approaches into generic drug development programs and regulatory submissions. The workshop will also identify commonalities in methodologies/workflows or in silico models supporting alternative BE approaches and clarify how a model master file may be leveraged to advance drug product development, facilitate regulatory assessment, and streamline drug product approval.
FDA and the CRCG—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
- Use of model integrated evidence to support demonstrations of BE in a regulatory context
- Use of the same or similar model or modeling strategy across multiple submissions related to complex drug products
- Mechanistic modeling approaches supporting BE assessments for oral drug products
- Applications of quantitative comparative approaches to support the development of complex generic drug products
- Case examples supporting the recently introduced concept of “model master files”
The generic and new drug industry, research organizations, academia, international regulatory agencies, and other parties interested in, or whose work supports, the development of generic drug products.