Guidance for robustness/ruggedness tests in method validation

This paper. is intended to give guidance in setting-up and interpreting a r obustness test. The different steps in a robustness test are discussed and illustrated with examples. The recommendations given for the different step s are based on approaches found in the literature, several case studies per formed by the authors and discussions of the authors within a commission of the French SFSTP (Societe Francaise des Sciences et Techniques Pharmaceuti ques). In the end of the paper a worked-out example is given of a robustnes s test case study set up and interpreted according to the guidelines. (C) 2 001 Elsevier Science B.V. All rights reserved.