
pmid: 12737539
A method is proposed for estimating the probability density function (PDF) of the individual bioequivalence metric. We show that under the usual assumption of independence of the various random variables, the computations are quite feasible. A program to evaluate the integrals needed for the computations has been written. Experimentation with this program shows that the pass/fail decision based on the computed PDF compares favorably with that based on the method suggested in a recent FDA Guidance (Jan. 2001).
Therapeutic Equivalency, United States Food and Drug Administration, Confidence Intervals, United States
Therapeutic Equivalency, United States Food and Drug Administration, Confidence Intervals, United States
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