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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