Block designs in method transfer experiments.

ABSTRACT

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. Estimates of reproducibility and repeatability may also be of interest. This article focuses on the application of various block designs that have been found useful in the comprehensive study of method transfer beyond the laboratory effect alone. An equivalence approach to the comparison of laboratories can still be carried out on either the least squares means or subject-specific means of the laboratories to justify a method transfer or to compare analytical methods.