Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability. (27th December 2015)

• Record Type: Journal Article
• Authors: Li, Jianghao; Chow, Shein-Chung
• Other Names: Su Steve Academic Editor.
• Is Part Of: Journal of probability and statistics. Volume 2015(2015)
• Publication Date: 2015-12-27
• Subjects: Probabilities -- Periodicals; Mathematical statistics -- Periodicals; Mathematical statistics; Probabilities; Periodicals; 519
• DOI: 10.1155/2015/298647
• Languages: English
• ISSNs: 1687-952X

Abstract

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.