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In silico pk simulations to explore the risks of inappropriate biowaiver decisions for bcs i and iii efflux transport substrates

  • At: 2014 FIP Congress in PSWC, Melbourne (Australia)
  • Type: Poster
  • By: SHAWAHNA, Ramzi (An-Najah National University, Pharmacy, Nablus, Palestinian Territory)
  • Co-author(s): Kortej (Division of Biopharmaceutics and Pharmacokinetics, University of Helsinki, Finl, Helsinki, Finland)
    Malkki (Division of Biopharmaceutics and Pharmacokinetics, University of Helsinki, Finl, Helsinki, Finland)
    Rostami-Hodjegan (School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Unite, Manchester, United Kingdom)
    Scherrmann (University Paris Descartes, France, Paris, France)
    Urtti (Centre for Drug Research, University of Helsinki, Finland, Helsinki, Finland)
    Yliperttula (Division of Biopharmaceutics and Pharmacokinetics, University of Helsinki, Finl, Helsinki, Finland)
  • Abstract:

    Background: Currently the FDA does not accept biowaiver applications for IR dosage forms containing BCS III products. However, The EMEA and WHO evaluate applications for BCS class III and require [quotright]very rapid[quotrightB]dissolution and qualitatively and quantitatively very similar composition. We conducted this study to evaluate the risks ..

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Last update 4 October 2019

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