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.