Assessing bioequivalence using genomic data.

Journal Article (Journal Article)

For approval of a generic drug product, the assessment of bioequivalence in drug absorption is usually considered as a surrogate for evaluation of drug efficacy and safety in clinical studies. For some drug products, the United States Food and Drug Administration indicates that the assessment of similarity between dissolution profiles may be used as a surrogate for assessment of bioequivalence. Along this line, we propose assessing bioequivalence using genomic data collected from the same individuals, assuming that there is an established relationship between pharmacokinetic and genomic data. Because there may be a bias in the prediction of pharmacokinetic data using genomic data and the variations in these two types of data are different, we propose to assess bioequivalence based on sensitivity analysis of prediction bias and variation difference within some predetermined limits. Our methods are derived for average, population, and individual bioequivalence.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Shao, J; Li, L

Published Date

  • November 2004

Published In

Volume / Issue

  • 14 / 4

Start / End Page

  • 869 - 880

PubMed ID

  • 15587969

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1081/BIP-200035420


  • eng

Conference Location

  • England