How Do We Translate Pre-clinical and Clinical Research into Drug Labeling?

The number of submissions to the FDA involving physiologically-based pharmacokinetic (PBPK) modeling has increased significantly over the past few years. PBPK modeling can be applied in drug discovery and development from the early stages prior to lead development where limited data are available as well as in early to late drug development. There are now a number of publications citing examples of the application of PBPK models for decision-making specific to candidate selection, first-in-human dose, assessment of DDI potential and assignment of appropriate study designs involving DDIs or inclusion/exclusion criteria for studies with drugs metabolized by polymorphic enzymes.

The pharmaceutical industry and regulators alike rely increasingly on modeling & simulation to fill knowledge gaps and address various questions raised during regulatory review, particularly with respect to the quantitative assessment of drug-drug interactions (DDIs) in the absence of clinical data or when the appropriate clinical study has not been performed. A validated PBPK model can be used to assist with dose selection in the presence of extrinsic factors and subsequently inform decisions relating to product labeling. In this webinar, Dr. Karen Rowland Yeo presented examples of the role of PBPK modeling in the regulatory approvals process.

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