Feasibility of Predicting Regional Lung Exposure from Systemic Pharmacokinetic (PK) Data of Generic OIDPs via Population PK

Author/sBulitta, J

Date:04/21/2023

Meeting Name:FDA and the Center for Research on Complex Generics (CRCG) Workshop on Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products

State:MD

City:Rockville