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ICCVAM Biennial Report 2020-2021

Biennial Progress Report 2020-2021 Interagency Coordinating Committee on the Validation of Alternative Methods

Grants to Support Development of PBPK Models

In January 2021, FDA CDER announced availability of grants to support development of PBPK models for bioequivalence studies for new generic drugs. CDER requested that proposals include scientifically justified IVIVE strategies, discuss how the models will address population variability, and describe a plan for how models would be verified and validated. The intent was to award a total of $600,000 over 2 years to one or two awardees.