Abstract:
FDA notes that PBPK modeling and simulation approaches are extensively used in regulatory submissions to predict the potential for drug-drug interactions and to support dosing recommendations for certain drugs when they are co-administered with metabolic enzyme modulators. However, challenges and knowledge gaps prevent PBPK modeling from being routinely used for specific regulatory decisions. Given the current limitations of the approach, it is important that the scientific community explore when, where, and how PBPK modeling and simulation may be applied in regulatory decision-making.
The purpose of this public workshop, was to:
- discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making;
- share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach;
- obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making;
- discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions
The FDA workshop allows us to stay updated on the latest FDA guidlines and best practices to help us always provide our clients with a high-quality, regulatory-compliant modeling for regulatory submission packages.
