Drugmakers Urge FDA to Add PBPK Modeling to Food Effects Guidance

Leading drugmakers are calling on the FDA to include the use of physiologically-based pharmacokinetic (PBPK) modeling in its draft guidance on assessing the effects of food on drugs in INDs and NDAs.

In written comments to the agency, Janssen, Novartis, Roche and Boehringer Ingelheim urged the agency to incorporate PBPK modeling into the guidance and allow its use in determining whether food-effect (FE) studies are required.

Janssen said PBPK modeling can be used to eliminate unnecessary FE studies. “With respect to FE studies, PBPK modeling can be used prospectively for to-be-marketed formulations and new dosing strategies to predict the effect of dose administration timing and meal intake,” the company said.

Novartis also called for the guidance to include PBPK absorption models as a data option for FE study waivers.

Roche said a PBPK model verified using food-effect data from preliminary assessment in Phase 1 pilot trials “can be used to predict the FE with formulation to be used in the pivotal trials or the to-be-marketed formulation.”