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245 00 a| Genotoxic impuritiesh| [electronic resource] :b| strategies for identification and control /c| edited by Andrew Teasdale.;

260 a| Hoboken, N.J. :b| Wiley,;

300 a| xiii, 428 p. :b| ill. ;c| 25 cm.;

504 a| Includes bibliographical references and index.;

505 0 a| 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 ... [et al.] -- 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 ... [et al.] -- 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.;

506 a| Available only to authorized users.;

538 a| Mode of access: World Wide Web;

650 0 a| Genetic toxicology.=| ^A215858;

650 0 a| Drugsx| Toxicology.=| ^A2811;

650 12 a| Mutagenicity Testsx| methods.=| ^A965889;

650 22 a| Drug Toxicityx| prevention & control.=| ^A961276;

650 22 a| Mutagensx| adverse effects.=| ^A965890;

650 22 a| Mutagensx| analysis.=| ^A948808;

650 22 a| Toxicogeneticsx| methods.=| ^A1205307;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Teasdale, Andrew.?| UNAUTHORIZED;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=661536;

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Genotoxic impurities strategies for identification and control / edited by Andrew Teasdale.

Other author	Teasdale, Andrew.
Format	Electronic
Publication Info	Hoboken, N.J. : Wiley,
Description	xiii, 428 p. : ill. ; 25 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Genetic toxicology. Drugs--Toxicology. Mutagenicity Tests--methods. Drug Toxicity--prevention & control. Mutagens--adverse effects. Mutagens--analysis. Toxicogenetics--methods.

Contents	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 ... [et al.] -- 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 ... [et al.] -- 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.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2010025374
ISBN	9780470499191 (cloth)

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