Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug...

Area of Science:

• Pharmaceutical Sciences
• Regulatory Science
• Drug Development

Background:

• FDA public workshop focused on best practices for using modeling in generic drug development.
• Model-integrated evidence (MIE) is increasingly used to support regulatory decisions for generic drug applications.
• Discussions highlighted the evolution and application of MIE in generic product assessment.

Purpose of the Study:

• To summarize insights and discussions from the 2022 FDA workshop on modeling for generic product development.
• To illustrate current and potential uses of MIE in informing generic drug development and regulatory decisions.
• To identify factors contributing to successful model-informed drug development programs.

Main Methods:

• Summary of discussions from a 2022 FDA public workshop.
• Review of applications of MIE in generic drug product development.
• Analysis of industry feedback on the use of modeling and simulation.

Main Results:

• MIE approaches are applied to long-acting injectable (LAI) products for efficient study designs.
• Modeling and simulation support virtual bioavailability (BE) assessments for locally acting and orally administered drugs.
• Industry utilizes MIE for formulation selection, pilot studies, and alternative BE study designs.

Conclusions:

• MIE offers significant potential to inform generic drug development and regulatory decision-making.
• Collaboration between regulatory agencies and industry is crucial for successful implementation of modeling approaches.
• Continued dialogue can enhance understanding of scientific and regulatory considerations for MIE in submissions.