VU Research Portal · 2005 · 91 citations · 0 references
PharmacyPharmaceutical AnalysisForensic ToxicologyImpurity ProfilingPharmaceutical ToxicologyImpurity Method DevelopmentImpurity Method ValidationImpurity QuantificationStress TestingToxicological Drug ScreeningDrug Impurity AnalysisImpurity Profiling Method DevelopmentPharmaceutical Impurity ProfilingRegulatory Stability TestingStability-indicating Impurity AssessmentStress Testing Validation
The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates relevant, generally predictive results for the development of a stability-indicating method.