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
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.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.