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In which cases can human studies be waived: The ground rules

  • In: C2 - Why is Dissolution Testing still needed? on Monday, 30 August 2010, 9:00-12:00
  • At: Lisbon (Portugal) (2010)
  • Type: Presentation
  • By: DRESSMAN, Jennifer (Goethe University, Frankfurt am Main, Germany)
  • Abstract:

    Although pharmacokinetic studies in humans represent the "gold standard" for establishing bioequivalence of drug products, several regulatory authorities (e.g. WHO, FDA, EMEA) have opened the way to alternative approaches. The methods are based on dissolution testing and thus represent savings in terms of both costs and unnecessary exposure of

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Last update 28 September 2023

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