METHODS OF DETERMINING CUTOFF POINTS

摘要

The present invention features a novel method for determining cutoff points in biological assays by calculating a kth percentile for a drug naive data set obtained from a biological assay. The kth percentile may be adjusted to account for assay variability at the kth percentile. The kth percentile may also be adjusted to account for variability in the assay response of a test sample collected after administration of the therapeutic agent. A preferred kth percentile is 90%. The method can be used on data that has a normal or non-normal distribution pattern. The cutoff point is used to determine whether a therapeutic agent has biological activity.