Request Copyright Permission

FDA Recommendations for Alternative Bioequivalence Approaches: Design and Rationale for In Vitro and In Vivo Studies

Bielski E, Boc ST.

Respiratory Drug Delivery 2024. Volume 1, 2024: 82-84.

Abstract:

Comparative clinical endpoint (CCEP) and pharmacodynamic (PD) bioequivalence (BE) studies, traditionally recommended in US Food and Drug Administration (FDA) product-specific guidances (PSGs), are challenging to conduct. FDA has explored in vitro, in vivo, and in silico study designs as alternative approaches that may be used in lieu of these clinical studies. Consequently, based on internal and external research project outcomes, as well as input from external discussions, several PSGs on suspension-based metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products have been developed with alternative BE approaches. These newly developed PSGs demonstrate FDA’s efforts to expand alternative BE approaches and highlight the additional study considerations needed when conducting these studies in lieu of the CCEP and PD BE studies.