Guideline o the Investigation of Bioequivalence

Study report synopses for bioequivalence or comparative bioavailability studies conducted during formulation development should also be included in Module 2.7. Bioequivalence studies comparing the product applied for with non-EU reference products should not be submitted and do not need to be included in the list of studies. 4.1.1 Study design

  Study, Investigation, Comparative, Bioequivalence, The investigation of bioequivalence