The contents of a software package for the experimental set-up and interpretation of ruggedness tests for mainly procedure related factors is presented. A ruggedness test is a part of method validation, which is becoming increasingly important, particularly in the pharmaceutical industry. However a ruggedness test is often not performed, due to the complexity and the many approaches possible. Therefore, after examining the literature and performing a number of case studies, a strategy was selected to determine the ruggedness of an analytical method. This strategy was implemented in a MATLAB software package, called RTS (Ruggedness Test Strategy). The program is designed to facilitate the selection of the designs and the interpretation of the results and to prevent or detect problems such as drifting of responses. The graphical interface, the on-line help menus, the default choices and the decision support system for the selection of factors and their levels, make the program user-friendly, so that it can easily be run by users having little experience with MATLAB or with ruggedness testing. The program contains both fractional factorial designs and Plackett-Burman designs. Some designs require a few experiments more than absolutely necessary so that they are suitable for statistical interpretation of the effects by means of a t-test. Others are minimal designs, which do not allow statistical interpretation with a t-test. The use of randomisation tests as an alternative statistical interpretation method for the significance of the effects was examined.
|Number of pages||1|
|Journal||Journal de Pharmacie de Belgique|
|Publication status||Published - 1 Dec 1998|