Acceptance Limits for Bioequivalence Studies

Abstract

At present, bioequivalence acceptance standards are the same for all drugs. the test article must exhibit pharmacokinetic parameters which are within the range of 80% to 120% of those which characterize the reference product (80-125% for log transformed data). However, there are arguments in favor of individual-izing the acceptance standards so as to allow for recognition of the unique pharmacokinetic and pharmacodynamic properties of any given drug. the present paper explores some of the factors which need to be taken into account if such changes in bioequivalence acceptance standards are to be implemented in a rational manner.