Utilization of bcs based biowaivers for approval of drug products: current practice
- At: Bangkok (Thailand) (2014)
- Type: Poster
- By: DRESSMAN, Jennifer (Goethe University, Pharmaceutical Technology, Frankfurt am main, Germany)
Background information: The biowaiver procedure based on the Biopharmaceutical Classification System (BCS) utilizes dissolution testing as a tool for bioequivalence evaluation instead of in vivo pharmacokinetic studies. Thus, the BCS-based biowaiver procedure helps to reduce the cost and improve the availability of generic products.
Aim: This.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.