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Combining In Vitro and In Silico Models to Demonstrate Bioequivalence of Orally Inhaled Drug Products

Ganley W, Rossi I, Budd G, Sadafi H, De Backer J.

Respiratory Drug Delivery 2023. Volume , 2023: 141-148.

Abstract:

Recent developments involving in vitro and in silico tools for orally inhaled drug products (OIDPs) have produced an extensive toolkit. However, demonstration of equivalence in exposure at the local site of action in the lung requires simultaneous consideration of the product, patient, and disease state, which none of these tools can achieve in isolation. A combined in vitro/in silico approach must therefore be used determine exposure at the local site of action in the lung. The culmination is an in silico clinical trial which simulates individual dosing events in patients and predicts meaningful endpoints. Such an approach has the potential to better inform regulatory decision making, product development and reduce the need for comparative clinical endpoint studies in the approval of generic inhaled drug products.