ABSTRACT
Oral inhalation drug products are drug-device combination products and have many complex issues that could impact efficacy and safety. Oral inhalation drug products incorporate a device, and therefore, evidence to support the efficacy and safety of the product must include information to support the performance of the entire product including formulation and device-related considerations. As complex dosage forms, the drug product is comprised of both the drug formulation and the device. Apart from drug substance, excipient, and other formulation issues, device characteristics can play a significant role in impacting the efficacy and safety of the drug product. This review presents regulatory considerations from a clinical perspective for orally inhaled drug products developed for asthma and COPD.
