Journal of pharmaceutical and biomedical analysis
Guidance for robustness/ruggedness tests in method validation
Contenu en anglais
Résumé
This paper is intended to give guidance in setting-up and interpreting a robustness test. The different steps in a robustness test are discussed and illustrated with examples. The recommendations given for the different steps are based on approaches found in the literature, several case studies performed by the authors and discussions of the authors within a commission of the French SFSTP (Société Française des Sciences et Techniques Pharmaceutiques). In the end of the paper a worked-out example is given of a robustness test case study set up and interpreted according to the guidelines.
Source et droits
Publiée par Journal of pharmaceutical and biomedical analysis, 2001. La recommandation elle-même se trouve à la source indiquée ici.
Prognia résume cette recommandation à des fins de consultation et d’enseignement. Il ne s’agit pas d’un avis médical. Vérifiez toujours la recommandation officielle et les protocoles locaux en vigueur avant de l’appliquer.
En bref
- Date de publication
- 2001
- S’applique à
- 🌐 International
- Pays d’origine
- 🇧🇪 Belgique
- Portée
- Internationale
- Revue
- Journal of pharmaceutical and biomedical analysis
- PubMed
Autres recommandations en autres
- The Canine Cognitive Dysfunction Syndrome Working Group guidelines for diagnosis and monitoring of canine cognitive dysfunction syndromeEuropean Respiratory Society · 2026
- Chinese guidelines for the clinical application of antibacterial drugs for febrile neutropenia (2026)Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026
