Utilization of bcs based biowaivers for approval of drug products: current practice

• In: Posters: Regulatory Sciences
• At: Bangkok (Thailand) (2014)
• Type: Poster
• Poster code: POS-RSC001
• By: DRESSMAN, Jennifer (Goethe University, Pharmaceutical Technology, Frankfurt am main, Germany)
• Abstract:

  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..

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