Statistical evaluation of individual bioequivalence

Abstract

Drug switchability requires the evidence of individual bioequivalence which -refers to the comparison of the closeness between the two distributions of the pharmacokinetic (PK) responses from the same subject obtained under the repeated administrations of the test and reference formulations. Advantages and drawbacks of the current statistical procedures for assessment of individual bioequivalence are discussed with emphasis on the aggregate-based criteria, An intersection-union test based on disaggregate criteria is proposed for the evaluation of individual bioequivalence. In addition, a modified aggregated criterion is suggested to overcome the drawbacks suffered by aggregate criteria. The relationships among different criteria are examined, and the performance of the procedures will be compared. A numerical example is given to illustrate the proposed procedures.