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      Logarithmic Transformation in Bioequivalence: Application with Two Formulations of Perphenazine

      , , , , , ,

      Journal of Pharmaceutical Sciences

      Wiley

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          Abstract

          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.

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          Author and article information

          Journal
          Journal of Pharmaceutical Sciences
          Journal of Pharmaceutical Sciences
          Wiley
          00223549
          February 1993
          February 1993
          : 82
          : 2
          : 138-144
          Article
          10.1002/jps.2600820205
          8445525
          © 1993

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