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Sample size used in bioequivalence studies around the world

  • At: Seville (Spain) (2022)
  • Type: Poster
  • Poster code: IPS-005
  • By: MESTRES, Conxita ()
  • Co-author(s): M R Ballester (Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Barcelona, Spain)
    Dr José Antonio Cordero, Professor
    Dr Conxita Mestres
  • Abstract:

    Background information:
    Bioequivalence (BE) studies for generic drug products compare the bioavailability of the generic drug with that of the reference product (brand) already marketed. The criteria for proving that a drug is BE vary among countries.
    The sample size of BE studies is the major factor in determining the probability of error..

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Last update 28 September 2023

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