Two-stage bioequivalence designs and problems need to focus on / 药物评价研究
Drug Evaluation Research
; (6): 593-599, 2017.
Article
in Zh
| WPRIM
| ID: wpr-619528
Responsible library:
WPRO
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.
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Index:
WPRIM
Language:
Zh
Journal:
Drug Evaluation Research
Year:
2017
Type:
Article