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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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Last update 4 October 2019

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