PMID: 8445525Feb 1, 1993Paper

Logarithmic transformation in bioequivalence: application with two formulations of perphenazine

Journal of Pharmaceutical Sciences
K K MidhaI J McGilveray

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.

References

Jan 1, 1991·Journal of Biopharmaceutical Statistics·L D Fisher

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Citations

Jan 1, 1993·European Journal of Clinical Pharmacology·P K YeungK K Midha
Jul 13, 2000·European Journal of Drug Metabolism and Pharmacokinetics·C J TimmerA F Cohen
Oct 31, 1998·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·K K MidhaJ W Hubbard
Nov 1, 1995·British Journal of Clinical Pharmacology·F L DegnerD Türck
Apr 1, 1994·Antimicrobial Agents and Chemotherapy·K GallicanoA Pakuts
Sep 1, 1994·Antimicrobial Agents and Chemotherapy·L RamboutG Garber
Feb 22, 2001·Antimicrobial Agents and Chemotherapy·B AuclairC A Peloquin
Feb 6, 2004·Journal of Pharmaceutical Sciences·Nathalie M-H PriymenkoPierre-Louis Toutain
Jul 12, 2008·Statistics in Medicine·Leena ChoiCharles Rohde
Nov 17, 2009·The Korean Journal of Physiology & Pharmacology : Official Journal of the Korean Physiological Society and the Korean Society of Pharmacology·Byung-Jin Ahn, Dong-Seok Yim
Jan 1, 1994·Scandinavian Journal of Gastroenterology. Supplement·K A BachmannL Levine
Feb 1, 1994·Alimentary Pharmacology & Therapeutics·T J SullivanK A Bachmann
Jul 2, 1998·Journal of Pharmaceutical Sciences·K K MidhaJ W Hubbard

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