An alternative derivation of the distribution of the individual bioequivalence metric.
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).
Bolton
Sanford
S
College of Pharmacy, University of Arizona, Tucson, Arizona 85750, USA. bolton@acninc.net
Sondhi
Mohan
M
DiLiberti
Charles
C
D016001:Confidence Intervals; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration