Use of jackknife influence profiles in bioequivalence evaluations

Generic drug product-development involves many bioavailability trials in an attempt to establish bioequivalence of the test drug product with an innovator's drug product. A major challenge for decision makers in the generic drug product-development process is to identify a successful test product based on the outcome of individual bioavailability trials, which may be misleading as a result of influential observations. The author identifies the need for a graphical diagnostic technique and then introduces such a technique, the jackknife influence profile, for the systematic scanning of influential observations. This review also describes the possible application of the technique in deriving the required reliable statistic values for bioequivalence assessment.