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

Zintzaras, E.; Bouka, P.; Kowald, Axel

Item

ITEM ACTIONSEXPORT

Add to Basket

Local TagsRelease HistoryDetailsSummary

Released

Journal Article

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

MPS-Authors

/persons/resource/persons50393

Kowald, Axel
Independent Junior Research Groups (OWL), Max Planck Institute for Molecular Genetics, Max Planck Society;

External Resource

No external resources are shared

Fulltext (restricted access)

There are currently no full texts shared for your IP range.

Fulltext (public)

There are no public fulltexts stored in PuRe

Supplementary Material (public)

There is no public supplementary material available

Citation

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.

Cite as: https://hdl.handle.net/11858/00-001M-0000-0010-8CC6-F

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.