Transcription of Robustness/ruggedness tests in method validation
{{id}} {{{paragraph}}}
Example: bachelor of science
Robustness/ruggedness tests in method validation
27/03/06. Guidance for Robustness/ruggedness tests in method validation Y. Vander Heydena, , J. Smeyers-Verbekea, Vandeginsteb and Massarta aVrije Universiteit Brussel, ChemoAC, Pharmaceutical Institute, Laarbeeklaan 103, 1090 Brussel, Belgium bUnilever Research Vlaardingen, 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 Selection of the factors Mixture-related factors Quantitative factors Qualitative factors Selection of the factor levels Quantitative and mixture factors Asymmetric intervals for quantitative factors Qualitative factors 3.
The definition for robustness/ruggedness applied is "The robustness/ruggedness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication …
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: