robustnessruggednesstestsinmethodvalidation（r o b u s t n e s s r u g g e d n e sstestsinmethodvalidation）.docVIP

Guidance for Robustness/Ruggedness Tests in Method Validation Y. Vander Heydena, A.Nijhuisb, J. Smeyers-Verbekea, B.G.M. Vandeginsteb and D.L. Massarta aVrije Universiteit Brussel, ChemoAC, Pharmaceutical Institute, Laarbeeklaan 103, 1090 Brussel, Belgium bUnilever Research Vlaardingen, P.O. Box 114, 3130 AC Vlaardingen, The Netherlands Content 1. Introduction Definitions Situating robustness in method development and validation Objectives of a robustness evaluation The steps in a robustness test 2. Selection of factors and levels 2.1. Selection of the factors 2.1.1. Mixture-related fac