In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances

The current risk assessment approach for addressing the safety of very small concentrations of genotoxic impurities (GTIs) in drug substances is the threshold of toxicological concern (TTC). The TTC is based on several conservative assumptions because of the uncertainty associated with deriving an e...

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Veröffentlicht in:	Regulatory toxicology and pharmacology 2010-07, Vol.57 (2-3), p.300-306
Hauptverfasser:	Bercu, Joel P., Morton, Stuart M., Deahl, J. Thom, Gombar, Vijay K., Callis, Courtney M., van Lier, Robert B.L.
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Cancer potency Carcinogenicity Databases, Factual Drug Contamination Forecasting Genotoxic Impurities In silico Mice Models, Theoretical Mutagens - toxicity Neoplasms - chemically induced Pharmaceutical Pharmaceutical Preparations - chemistry Pharmaceutical Preparations - classification Pharmaceutical Preparations - standards Rats Risk Assessment Software Structure-Activity Relationship TD50 Threshold of toxicological concern
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