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" Genotoxic impurities "
edited by Andrew Teasdale.
Document Type
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BL
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Record Number
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618961
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Doc. No
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dltt
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Title & Author
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Genotoxic impurities : strategies for identification and control /\ edited by Andrew Teasdale.
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Publication Statement
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Hoboken, N.J. :: Wiley,, c2010.
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ISBN
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9780470499191
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Bibliographies/Indexes
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Includes bibliographical references and index.
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Contents
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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.
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Subject
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Genetic toxicology.
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Subject
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Drugs-- Toxicology.
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Subject
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Mutagenicity Tests-- methods.
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Subject
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Drug Toxicity-- prevention control.
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Subject
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Mutagens-- adverse effects.
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Subject
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Mutagens-- analysis.
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Subject
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Toxicogenetics-- methods.
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Added Entry
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Teasdale, Andrew.
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Added Entry
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Wiley Online Library (Online service)
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