PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies

The Food and Drug Administration (FDA) is soliciting research proposals to expand the application of oral Physiologically Based Pharmacokinetic (PBPK) models to emerging issues in generic drug regulation. The proposed research should include plans for the development and application of oral PBPK models that can simulate the results of bioequivalence studies and support the Office of Generic Drugs (OGD) in addressing issues such as the implementation of ICH guideline M9, development of ICH guideline M13, and evaluation of alternative BE study designs motivated by public health emergencies. The simulations should include prediction of the results of fed BE studies, evaluation of excipient differences, evaluation of dissolution differences, identification of the most accurate analyte for BE determination, and evaluating modifications to BE study designs related to changes in the clinical trial environment due to public health emergencies. • The proposed research should focus on oral PBPK models and their application to generic drug regulation. • The research should address emerging issues in generic drug regulation, including the implementation of ICH guideline M9 and the development of ICH guideline M13. • The simulations should include prediction of the results of fed BE studies and evaluation of excipient and dissolution differences. • The research should identify the most accurate analyte for BE determination and evaluate modifications to BE study designs related to changes in the clinical trial environment due to public health emergencies.