Pharmaceutical Research

, Volume 9, Issue 11, pp 1380–1385

An Alternative Approach for Assessment of Rate of Absorption in Bioequivalence Studies

Authors

  • Mei-Ling Chen
    • Division of Bioequivalence, HFD-655, Office of Generic Drugs (MPN II)Center for Drug Evaluation and Research, Food and Drug Administration
Article

DOI: 10.1023/A:1015842425553

Cite this article as:
Chen, M. Pharm Res (1992) 9: 1380. doi:10.1023/A:1015842425553

Abstract

The partial area method was investigated for evaluation of equivalency in the rate of absorption of immediate release formulations. The applicability of the method was demonstrated with four drugs with different pharmacokinetic/pharmacodynamic characteristics. The confidence interval approach currently employed for bioequivalence determinations was applied to the relevant absorption parameters, including C max and partial AUCs. The method was found to be more discriminating than C max and/or T max in the evaluation of the absorption rate of drugs. The cutoff time or point for partial AUC calculation may vary with the type of drug under study, depending on its clinical use and onset of action. The method was shown to be useful in the assessment of rate of absorption in bioequivalence studies.

bioequivalence absorption rate partial AUC truncated AUC peak concentration time to peak

Copyright information

© Plenum Publishing Corporation 1992