Genotoxic impurities : strategies for identification and control /

Bibliographic Details
Other Authors: Teasdale, Andrew
Format: Book
Language:English
Published: Hoboken, N.J. : Wiley, c2011
Subjects:
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245 0 0 |a Genotoxic impurities :  |b strategies for identification and control /  |c edited by Andrew Teasdale 
260 |a Hoboken, N.J. :  |b Wiley,  |c c2011 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
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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 
650 0 |a Drugs  |x Toxicology 
650 0 |a Genetic toxicology 
650 7 |a Drugs  |x Toxicology  |2 fast 
650 7 |a Genetic toxicology  |2 fast 
650 1 2 |a Mutagenicity Tests  |x methods 
650 2 2 |a Drug Toxicity  |x prevention & control 
650 2 2 |a Mutagens  |x adverse effects 
650 2 2 |a Mutagens  |x analysis 
650 2 2 |a Toxicogenetics  |x methods 
700 1 |a Teasdale, Andrew  |1 http://viaf.org/viaf/121637241 
776 0 8 |i Print version:  |t Genotoxic impurities  |d Hoboken, N.J. : Wiley, c2011  |z 9780470499191  |w (DLC) 2010025374 
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