Please use this identifier to cite or link to this item: https://doi.org/10.1155/2015/298647
Title: Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability
Authors: Li, J
Chow, S.-C 
Issue Date: 2015
Citation: Li, J, Chow, S.-C (2015). Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability. Journal of Probability and Statistics 2015 : 298647. ScholarBank@NUS Repository. https://doi.org/10.1155/2015/298647
Rights: Attribution 4.0 International
Abstract: 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. © 2015 Jianghao Li and Shein-Chung Chow.
Source Title: Journal of Probability and Statistics
URI: https://scholarbank.nus.edu.sg/handle/10635/180922
ISSN: 1687952X
DOI: 10.1155/2015/298647
Rights: Attribution 4.0 International
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