Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability

Joint Authors

Li, Jianghao
Chow, Shein-chung

Source

Journal of Probability and Statistics

Issue

Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-13, 13 p.

Publisher

Hindawi Publishing Corporation

Publication Date

2015-12-27

Country of Publication

Egypt

No. of Pages

13

Main Subjects

Mathematics

Abstract EN

For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study.

A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%).

This approach is considered a one-parameter approach, which does not account for possible heterogeneity of variability between drug products.

In this paper, we study a two-parameter approach (i.e., confidence region approach) for assessing bioequivalence, which can also be applied to assessing biosimilarity of biosimilar products.

The proposed confidence region approach is compared with the traditional one-parameter approach both theoretically and numerically (i.e., simulation study) for finite sample performance.

American Psychological Association (APA)

Li, Jianghao& Chow, Shein-chung. 2015. Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability. Journal of Probability and Statistics،Vol. 2015, no. 2015, pp.1-13.
https://search.emarefa.net/detail/BIM-1069988

Modern Language Association (MLA)

Li, Jianghao& Chow, Shein-chung. Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability. Journal of Probability and Statistics No. 2015 (2015), pp.1-13.
https://search.emarefa.net/detail/BIM-1069988

American Medical Association (AMA)

Li, Jianghao& Chow, Shein-chung. Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability. Journal of Probability and Statistics. 2015. Vol. 2015, no. 2015, pp.1-13.
https://search.emarefa.net/detail/BIM-1069988

Data Type

Journal Articles

Language

English

Notes

Includes bibliographical references

Record ID

BIM-1069988