机构:
BASF Pharma, Biostat & Data Management, Nottingham, EnglandBASF Pharma, Biostat & Data Management, Nottingham, England
Channon, EJ
[1
]
机构:
[1] BASF Pharma, Biostat & Data Management, Nottingham, England
来源:
DRUG INFORMATION JOURNAL
|
2000年
/
34卷
/
02期
关键词:
dose response;
active control equivalence;
equivalence testing;
multiple comparisons;
interpolation;
D O I:
暂无
中图分类号:
R19 [保健组织与事业(卫生事业管理)];
学科分类号:
摘要:
Some developments are described in the case of multidose equivalence studies (multiple doses of the test substance and one dose of the reference). If equivalence cannot be proven for the rest substance at one of the doses studied, the procedure uses linear interpolation to examine intermediate doses. This greatly increases the power of the equivalence testing procedure, provided that equivalence for an intermediate nose only is considered an acceptable result of the study. The closed test procedure for equivalence testing of the doses studied is also described in order to clarify methods presented in other statistical publications. it is often difficult to specify the equivalence criterion (delta) precisely, although it is taken as a known constant in many statistical publications. It is recommended that results be presented in a form that allows them to be checked against several different values of delta.