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