How to calculate the one-sided 95% upper confidence bound for the IP of a bioassay (USP <1033> example)
USP <1033> is a validation guidance to support (cell-based) assay validation. It contains (simulated) validation data and the results of numerical values for different validation parameters. Variant component estimates can be derived by applying a mixed effects model on these data. This is relatively straightforward using JMP. However, I struggle with the following: USP <1033> recommends to re...