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FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies

Walenga RL.

Respiratory Drug Delivery 2024. Volume 1, 2024: 85-87.

Abstract:

Several newly issued product specific guidance (PSG) documents from the US Food and Drug Administration (FDA) include detailed language on the potential use of in silico modeling to support bioequivalence (BE) determination for generic locally acting orally inhaled drug products. These documents recommend that in silico modeling may be used to establish biorelevant BE limits for recommended in vitro and in vivo studies to potentially modify BE acceptance criteria, among other potential applications. To achieve the intended purpose of an in silico approach, model credibility must be established, for which FDA recommends adopting a risk-based approach. Internal research is currently ongoing at FDA, with the goals of further refining PSG recommendations for locally acting orally inhaled drug products and providing a complete use case.