In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey-Reference-Cited by-同舟云学术

In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey

Published:2012-04 Issue:3 Volume:62 Page:449-455
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Dobo Krista L.,Greene Nigel,Fred Charlotta,Glowienke Susanne,Harvey James S.,Hasselgren Catrin,Jolly Robert,Kenyon Michelle O.,Munzner Jennifer B.,Muster Wolfgang,Neft Robin,Vijayaraj Reddy M.,White Angela T.,Weiner Sandy

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference23 articles.

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2. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development;Dobo;Regul. Toxicol. Pharmacol.,2006

3. European Medicines Agency, Guideline on the Limits of Genotoxic Impurities. 2006.

4. The evaluation of the gentoxic potential of impurities;Glowienke,2010

5. Knowledge-based expert systems for toxicity and metabolism prediction: DEREK, StAR and METEOR;Greene;SAR QSAR Environ. Res.,1999

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