57935

strategies for identification and control

edited by Andrew Teasdale

Wiley Hoboken, N.J.

c2010

xiii, 428 p. : ill.

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. M�uller -- 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.

AU Teasdale, Andrew

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