We appreciate you letting us know that bioequivalence for OINDPs is a topic of interest.
Demonstrating bioequivalence for orally inhaled products remains a complex and evolving area, with increasing regulatory interest in the use of in vitro methods to support or potentially reduce reliance on clinical endpoint studies.
If you would like to learn more about current regulatory expectations or testing strategies for inhaled product bioequivalence, explore the resources below or contact our team.
