Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

Area of Science:

• Pharmacokinetics and Pharmacodynamics
• Computational Science
• Drug Development

Background:

• Growing adoption of modeling and simulation (M&S) in the USA for complex generic drug product development and approval.
• Introduction of mechanistic modeling and model-integrated evidence (MIE) as key components in regulatory submissions.
• Need for standardized approaches to support the increasing complexity of generic drug products.

Approach:

• Workshop session focused on exploring the potential for model reuse in complex generic drug development.
• Presentations and panel discussions involving stakeholders from the U.S. Food and Drug Administration (FDA), academia, and industry.
• Introduction of concepts like platform performance assessment and MIE standardization for model reuse frameworks.

Key Points:

• Exploration of model reuse potential for mechanistic models and MIE frameworks.
• Assessment of model capabilities in capturing formulation and product differences.
• Identification of challenges in model validation for diverse drug product classes (topical, inhaled, ophthalmic, long-acting injectables).

Conclusions:

• Emphasis on the necessity of continued communication between the FDA and the generic drug industry.
• Call for fostering the maturation of M&S through meetings and FDA-published guidance.
• Workshop provided insights into the current state of M&S for complex generics and opportunities for cross-product model application.