Two-stage bioequivalence designs and problems need to focus on
10.7501/j.issn.1674-6376.2017.05.003
- VernacularTitle:两阶段生物等效性研究的试验设计及关注要点
- Author:
Hua SUN
;
Dahu LIANG
;
Haitang XIE
- Keywords:
bioequivalence study;
two-stage design;
adaptive design;
sample size recalculation;
power;
size of test
- From:
Drug Evaluation Research
2017;40(5):593-599
- CountryChina
- Language:Chinese
-
Abstract:
Two-stage designs for the assessment of bioequivalence have been recently accepted in various regulatory authorities.However controlling type Ⅰ error rates around 5％ at targeted power is still a great challenge for applying two-stage method.This paper reviewed the feature of present designs of the two-stage bioequivalence.The decision tree,nominal significance level,and sample size recalculation in previously published methods were also introduced in detail,which would be referential for domestic sponsors in the study of two-stage design bioequivalence.
