04960cam a2200733Ma 4500 ocn698591455 OCoLC 20171119104308.0 m o d cr mn||||||||| 100617s2010 njua ob 001 0 eng d 2010025374 9780470929360 (electronic bk.) 0470929367 (electronic bk.) 9780470929377 (electronic bk.) 0470929375 (electronic bk.) 9780470499191 (cloth) 0470499192 (cloth) 10.1002/9780470929377 doi AU@ 000049641632 AU@ 000053277681 DEBBG BV041911174 DEBSZ 430945906 DKDLA 820120-katalog:000557206 NZ1 14255775 DEBBG BV043392700 (OCoLC)698591455 (OCoLC)701311237 (OCoLC)705868750 (OCoLC)961561954 (OCoLC)962625401 10.1002/9780470929377 Wiley InterScience http://www3.interscience.wiley.com E7B eng pn E7B OCLCQ OSU OCLCQ IDEBK OCLCF DKDLA OCLCQ DG1 EBLCP YDXCP N$T UKDOC NLGGC DEBSZ OCLCQ COO OCLCQ DEBBG AZK MAIN RA1224.3 .G463 2010eb QU 450 G3353 2011 HEA 039060 bisacsh MED 107000 bisacsh 616/.042 22 Genotoxic impurities : strategies for identification and control / edited by Andrew Teasdale. [electronic resource] Hoboken, N.J. : Wiley, ©2010. 1 online resource (xii, 428 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier data file rda Bibliography Includes bibliographical references and index. Historical overview of the development of genotoxic impurities guidelines and their impact / R. Ogilvie, A. Teasdale -- Development of the threshold of toxicological concern concept (TTC) and its relationship to duration of exposure / A. Brigo, L. Müller -- Genetic toxicity testing to qualify alerting impurities / M. O'Donovan -- Use of structure activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities / S. Glowienke, C. Hasselgren -- Compound-specific risk assessments for genotoxic impurities : examples and issues / A. Teasdale, C. Humfrey -- Human genotoxic metabolites : identification and risk / K. Dobo, D. Walker, A. Teasdale -- Genotoxic thresholds / G. Jenkins [and others] -- Genotoxic impurities : a risk in perspective? / D. Elder, J. Harvey -- Strategies for the evaluation of genotoxic impurity risk / A Teasdale, S. Fenner, D. Elder -- Analysis of genotoxic impurities : review of approaches / D. Elder -- Development of a strategy for analysis of genotoxic impurities / Andrew Baker -- Strategic approaches to the chromatographic analysis of genotoxic impurities / Frank David [and others] -- Analysis of genotoxic impurities by nuclear magnetic resonance (NMR) spectroscopy / Andrew Philips -- Mechanism and processing parameters affecting the formation of sulfonate esters : summary of the PQRI studies : PQRI working group / Andrew Teasdale -- Aspects to consider when devising a strategy to understand if low level API/DP degradants have the potential for genotoxicity / Alan P. McKeown, Andrew Teasdale. This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. T. Print version record. Genetic toxicology. Drugs Toxicology. Mutagenicity Tests methods. Drug Toxicity prevention & control. Mutagens adverse effects. Mutagens analysis. Toxicogenetics methods. HEALTH & FITNESS Diseases Genetic. bisacsh MEDICAL Genetics. bisacsh Drugs Toxicology. fast (OCoLC)fst00898958 Genetic toxicology. fast (OCoLC)fst00940097 Electronic books. Teasdale, Andrew. Print version: Genotoxic impurities. Hoboken, N.J. : Wiley, ©2010 9780470499191 (DLC) 2010025374 (OCoLC)643443212 http://onlinelibrary.wiley.com/book/10.1002/9780470929377 Wiley Online Library ddc BK 204887 204887