Complex Delivery Routes and Generics: The Next Frontier for PBBM/PBPK Modeling

Authors: Spires J
Conference: CRS
Software: GastroPlus®
Division: Simulations Plus


  • 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

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