Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

Area of Science:

• Pharmacokinetics and Drug Metabolism
• Regulatory Science
• Pharmaceutical Development

Background:

• Model Informed Drug Development (MiDD) utilizes quantitative tools to predict in vivo drug exposure.
• Physiologically Based Pharmacokinetic (PBPK) modeling is a key tool within MiDD, aiming to reduce development costs and accelerate patient access to medicines.

Purpose of the Study:

• To provide an overview of PBPK modeling approaches specifically for generic drug development.
• To emphasize the application of PBPK modeling in bio-waiver submissions.
• To address common pitfalls and offer practical guidance for model-based justifications in regulatory submissions.

Main Methods:

• Review of PBPK modeling approaches relevant to generic drug development.
• Focus on bio-waiver applications and regulatory submission strategies.
• Inclusion of in-house case studies to illustrate practical implementation.

Main Results:

• Identification of common challenges and pitfalls in applying PBPK models for regulatory deficiencies.
• Demonstration of a clear pathway for PBPK model-based justifications for bio-waivers through case studies.
• Potential reduction in the gap between theoretical PBPK knowledge and practical application in generic drug development.

Conclusions:

• PBPK modeling is a valuable tool in generic drug development, particularly for supporting bio-waiver applications.
• Practical case studies can bridge the gap between PBPK theory and its regulatory application.
• This work provides a roadmap for utilizing PBPK modeling to overcome regulatory hurdles in generic drug development.