Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Sample Size• Minimum Number of Subjects• 12 – WHO, EU, CAN, NZ, AUS, Malaysia, Argentina,ASEAN States, South Africa (20 for MR).• 12 (?) – USA: The total number of subjects in thestudy should provide adequate power for BE demonstration[…]. For modified-release products, a pilotstudy can help determine the sampling schedule toassess lag time and dose dumping. A pilot study thatdocuments BE may be appropriate, provided its designand exe-cution are suitable and a sufficient number ofsubjects (e.g., 12) have completed the study.• 24 – Saudia Arabia (12 – 24 if statistically justifiable).• 24 – Brazil.Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 40