Introduction
- Generic drug development for locally acting drug products is a fast-growing field of interest
- For locally acting drug products, traditional bioequivalence (BE) approaches used with orally administered drugs may not be relevant or applicable
- BE for locally acting products may be assessed through in vitro and/or in vivo testing; however, in vivo testing may be difficult or expensive, especially when assessing local concentration or effect data
By Jessica Spires
CRS Annual Meeting & Expo Montreal Canada, July 12, 2022