Two-stage bioequivalence designs and problems need to focus on / 药物评价研究
Drug Evaluation Research
;
(6): 593-599, 2017.
Artigo
em Chinês
| WPRIM
| ID: wpr-619528
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
Drug Evaluation Research
Ano de publicação:
2017
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS