FDA/CRCG Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products – 04/20/2023

FDA recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs) often involve study designs for conducting comparative clinical endpoint (CCEP) and pharmacodynamic (PD) BE studies.