Recently, FDA told a medical device start-up company that, in regard to the company’s proposed clinical trial, “The equivalence of the device to the predicate can be demonstrated if the confidence ...

An expected volume coefficient (EV) is defined and proposed to displace volume and selectivity as criteria for the evaluation of confidence sets, and a proposal for evaluation is given. This proposal ...

To compare proportions with several independent binomial samples, we recommend a method of constructing simultaneous confidence intervals that uses the studentized range distribution with a score ...