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  Biometrical evaluation of bioequivalence trials using a bootstrap individual direct curve comparison method.

Zintzaras, E., Bouka, P., & Kowald, A. (2002). Biometrical evaluation of bioequivalence trials using a bootstrap individual direct curve comparison method. European Journal of Drug Metabolism and Pharmacokinetics, 27(1), 11-16.

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Genre: Journal Article
Alternative Title : Eur J Drug Metab Pharmacokinet

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 Creators:
Zintzaras, E., Author
Bouka, P., Author
Kowald, Axel1, Author              
Affiliations:
1Independent Junior Research Groups (OWL), Max Planck Institute for Molecular Genetics, Max Planck Society, ou_1433554              

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 Abstract: Bioequivalence of two medicinal, or veterinary, products is established by comparing the mean of bioavailability measures, such as AUC and Cmax, following administration of the test (T) and reference (R) products. However, the use of these parameters has several drawbacks, e.g. they do not take into consideration the overall pharmacokinetic profile shape. Therefore, concerns have been raised regarding their appropriateness for assessment of bioequivalence. To overcome the limitations of these bioequivalence parameters, direct curve comparison metrics methods were recently proposed on an average basis. In this paper, an individual based direct curve comparison method for assessing bioequivalence is proposed. The bioequivalence of T and R in each subject is evaluated by a new curve comparison metrics delta. The metrics delta is the absolute sum of the difference between two curves. The significance of the metrics for each subject is assessed by bootstrapping. An overall bioequivalence of T and R may be considered if less than 25% of the subjects show statistically different profiles.

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Language(s): eng - English
 Dates: 2002
 Publication Status: Published in print
 Pages: -
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 Table of Contents: -
 Rev. Type: -
 Identifiers: eDoc: 29238
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Title: European Journal of Drug Metabolism and Pharmacokinetics
  Alternative Title : Eur J Drug Metab Pharmacokinet
Source Genre: Journal
 Creator(s):
Affiliations:
Publ. Info: -
Pages: - Volume / Issue: 27 (1) Sequence Number: - Start / End Page: 11 - 16 Identifier: -