Two-stage bioequivalence designs and problems need to focus on / 药物评价研究

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.

Research progress on case-control study / 中华流行病学杂志

Several new varients related to the case-control designs have been developed in the recent decades,and this article briefly summarized four new designs:two-stage design,case-specular study,exposure-crossover study and case-case-time-control study.This paper involved principles of study design,requisites for application,advantages and disadvantages on all the studies.

Using two-stage case-control designs to study the genome-wide association / 中华流行病学杂志

Genome-wide association study is an important approach to identify common genetic variants that predispose to human disease. Because of the high cost of genotyping on hundreds of thousands of markers on thousands of subjects, a more cost-effective two-stage case-control design is applied by most genome-wide association studies. To describe the design and statistical methods of the two-stage case-control study, this paper introduces the principles of two-stage case-control design, its implementing steps in genome-wide association study and the features of its application.The method is illustrated with an example.