Scientific Publications by FDA Staff

CPT Pharmacometrics Syst Pharmacol 2019 Jun;8(6):359-70

In silico methods for development of generic drug-device combination orally inhaled drug products.

Walenga RL, Babiskin AH, Zhao L

Development of generic single-entity drug-device combination products for orally inhaled drug products (OIDPs) is challenging, due in part to the complex nature of device design characteristics, and to the difficulties associated with establishing bioequivalence (BE) for a locally-acting drug product delivered to the site of action in the lung. This review examines in silico models which may be used to support development of generic OIDPs, and how model credibility may be assessed.