Data re-analysis after the finish of bioequivalence studies by using bootstrap method
10.13699/j.cnki.1001-6821.2018.03.042
- VernacularTitle:用自助抽样法对生物等效性研究数据进行再分析
- Author:
Min-Ji WEI
1
;
Hong CUI
;
Pu ZHANG
Author Information
1. 北京大学第一医院临床药理研究所
- Keywords:
bioequivalence;
pilot bioequivalent study;
bootstrap
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(3):332-334
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide a data re-analysis method after finish of bioequivalence studies,and apply this method in the decisionmaking.Methods Bootstrap re-sampling method was used for the bioequivalence data analysis.Each time,a pre-specified number of subjects were re-sampled,and the bioequivalence result was calculated.After the repetition for 2000 times,the failure rates of bioequivalence results were calculated.Results The data re-analysis was implemented in 3 cases of bioequivalence studies.Case 1 was a pilot bioequivalence study with fewer subjects enrolled,the results showed the success rate of further bioequivalence study could be improved by the increase of the size of subjects enrolled;case 2 was a failure bioequivalence study,the bootstrap results showed further bioequivalence study would still have a higher rate of failure;case 3 was a successful bioequivalence study,the results showed less than the actual number of subjects enrolled could still acquire bioequivalence results.Conclusion Bootstrap method provides a means to re-analyze the bioequivalence data for decision-making.The data acquired by using bootstrap support the inclusion of a larger sample size for the bioequivalence studies in order to acquire a higher success rate of passing bioequivalence test.
