Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability
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% confidenc...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Probability and Statistics |
| Online Access: | http://dx.doi.org/10.1155/2015/298647 |
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| author | Jianghao Li Shein-Chung Chow |
| author_facet | Jianghao Li Shein-Chung Chow |
| author_sort | Jianghao Li |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-6108de59e5f04d7fa5bed5f7db3d11b1 |
| institution | Kabale University |
| issn | 1687-952X 1687-9538 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Probability and Statistics |
| spelling | doaj-art-6108de59e5f04d7fa5bed5f7db3d11b12025-02-03T01:31:58ZengWileyJournal of Probability and Statistics1687-952X1687-95382015-01-01201510.1155/2015/298647298647Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of VariabilityJianghao Li0Shein-Chung Chow1School of Medicine, Duke University, Durham, NC 27705, USASchool of Medicine, Duke University, Durham, NC 27705, USAFor 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.http://dx.doi.org/10.1155/2015/298647 |
| spellingShingle | Jianghao Li Shein-Chung Chow Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability Journal of Probability and Statistics |
| title | Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability |
| title_full | Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability |
| title_fullStr | Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability |
| title_full_unstemmed | Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability |
| title_short | Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability |
| title_sort | confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability |
| url | http://dx.doi.org/10.1155/2015/298647 |
| work_keys_str_mv | AT jianghaoli confidenceregionapproachforassessingbioequivalenceandbiosimilarityaccountingforheterogeneityofvariability AT sheinchungchow confidenceregionapproachforassessingbioequivalenceandbiosimilarityaccountingforheterogeneityofvariability |