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The rationale for using the logarithmic transformation on concentration-dependent
pharmacokinetic parameters a priori is presented. This rationale is based on theoretical
pharmacokinetic and statistical grounds, but is also applicable to the practice of
physicians in dealing with variations of drug treatment within and between patients.
The implications of the transformation on data analysis, specifically analysis of
variance, and estimation and inference from the analysis as it pertains to bioequivalence
decisions are explored. Implementation of the transformation is shown, with an example
of two perphenazine formulations in a single-dose crossover study. It is concluded
that the transformation has to be accepted on theoretical grounds because sample sizes
are too small in bioequivalence studies and too susceptible to extreme values to state
with any certainty the actual distribution of pharmacokinetic parameters or their
differences within a subject.