ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
作者： Andrew Teasdale
DOI: 10.1002/9781118971147.CH24
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sci-hub.se 参考文章(36)
Hermann M. Bolt, Quantification of endogenous carcinogens: The ethylene oxide paradox Biochemical Pharmacology. ,vol. 52, pp. 1- 5 ,(1996) , 10.1016/0006-2952(96)00085-8
Nigel Greene, Krista L. Dobo, Michelle O. Kenyon, Jennifer Cheung, Jennifer Munzner, Zhanna Sobol, Gregory Sluggett, Todd Zelesky, Andreas Sutter, Joerg Wichard, A practical application of two in silico systems for identification of potentially mutagenic impurities. Regulatory Toxicology and Pharmacology. ,vol. 72, pp. 335- 349 ,(2015) , 10.1016/J.YRTPH.2015.05.008
Chris Barber, Alexander Amberg, Laura Custer, Krista L. Dobo, Susanne Glowienke, Jacky Van Gompel, Steve Gutsell, Jim Harvey, Masamitsu Honma, Michelle O. Kenyon, Naomi Kruhlak, Wolfgang Muster, Lidiya Stavitskaya, Andrew Teasdale, Jonathan Vessey, Joerg Wichard, Establishing best practise in the application of expert review of mutagenicity under ICH M7. Regulatory Toxicology and Pharmacology. ,vol. 73, pp. 367- 377 ,(2015) , 10.1016/J.YRTPH.2015.07.018
George S. Bailey, Ashok P. Reddy, Clifford B. Pereira, Ulrich Harttig, William Baird, Jan M. Spitsbergen, Jerry D. Hendricks, Gayle A. Orner, David E. Williams, James A. Swenberg, Nonlinear cancer response at ultralow dose: a 40800-animal ED(001) tumor and biomarker study. Chemical Research in Toxicology. ,vol. 22, pp. 1264- 1276 ,(2009) , 10.1021/TX9000754
Leslie Thomas Stayner, Larry Elliott, Leo Blade, Richard Keenlyside, William Halperin, A retrospective cohort mortality study of workers exposed to formaldehyde in the garment industry. American Journal of Industrial Medicine. ,vol. 13, pp. 667- 681 ,(1988) , 10.1002/AJIM.4700130606
I.C. Munro, R.A. Ford, E. Kennepohl, J.G. Sprenger, Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology. ,vol. 34, pp. 829- 867 ,(1996) , 10.1016/S0278-6915(96)00049-X
Andrew Teasdale, Edward J. Delaney, Stephen C. Eyley, Karine Jacq, Karen Taylor-Worth, Andrew Lipczynski, Wilfried Hoffmann, Van Reif, David P. Elder, Kevin L. Facchine, Simon Golec, Rolf Schulte Oestrich, Pat Sandra, Frank David, A Detailed Study of Sulfonate Ester Formation and Solvolysis Reaction Rates and Application toward Establishing Sulfonate Ester Control in Pharmaceutical Manufacturing Processes Organic Process Research & Development. ,vol. 14, pp. 999- 1007 ,(2010) , 10.1021/OP900301N
Mark W. Powley, (Q)SAR assessments of potentially mutagenic impurities: a regulatory perspective on the utility of expert knowledge and data submission. Regulatory Toxicology and Pharmacology. ,vol. 71, pp. 295- 300 ,(2015) , 10.1016/J.YRTPH.2014.12.012
Joel P. Bercu, Wherly P. Hoffman, Cindy Lee, Daniel K. Ness, Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance Regulatory Toxicology and Pharmacology. ,vol. 51, pp. 270- 277 ,(2008) , 10.1016/J.YRTPH.2008.04.011
Edward J. Delaney, An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals Regulatory Toxicology and Pharmacology. ,vol. 49, pp. 107- 124 ,(2007) , 10.1016/J.YRTPH.2007.06.008