Block designs in method transfer experiments.

Method transfer is a part of the pharmaceutical development process in which an analytical (chemical) procedure developed in one laboratory (typically the research laboratory) is about to be adopted by one or more recipient laboratories (production or commercial operations). The objective is to show that the recipient laboratory is capable of performing the procedure in an acceptable manner. In the course of carrying out a method transfer, other questions may arise related to fixed or random factors of interest, such as analyst, apparatus, batch, supplier of analytical reagents, and so forth.

Double bootstrapping a tolerance limit.

We consider the problem of constructing tolerance limits in the context of a one-way random effects model The usual parametric method for calculating tolerance intervals is based on the normality assumption. However, in practice, we frequently observe nonnormally distributed data. We propose the use of the double bootstrap (or nested bootstrap) method to estimate tolerance limits, which allows us to relax the normality assumption.