Genotoxic impurities
Subtitle: strategies for identification and control
By: edited by Andrew Teasdale
Publisher: Wiley
Published: 2011
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470499191
Notes: Includes bibliographical references and index.
Table of contents: title: Historical overview of the development of genotoxic impurities guidelines and their impact / R. Ogilvie, A. Teasdale; title: Development of the threshold of toxicological concern concept (TTC) and its relationship to duration of exposure / A. Brigo, L. Müller; title: Genetic toxicity testing to qualify alerting impurities / M. O'Donovan; title: Use of structure activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities / S. Glowienke, C. Hasselgren; title: Compound-specific risk assessments for genotoxic impurities : examples and issues / A. Teasdale, C. Humfrey; title: Human genotoxic metabolites : identification and risk / K. Dobo, D. Walker, A. Teasdale; title: Genotoxic thresholds / G. Jenkins ... [et al.]; title: Genotoxic impurities : a risk in perspective? / D. Elder, J. Harvey; title: Strategies for the evaluation of genotoxic impurity risk / A Teasdale, S. Fenner, D. Elder; title: Analysis of genotoxic impurities : review of approaches / D. Elder; title: Development of a strategy for analysis of genotoxic impurities / Andrew Baker; title: Strategic approaches to the chromatographic analysis of genotoxic impurities / Frank David ... [et al.]; title: Analysis of genotoxic impurities by nuclear magnetic resonance (NMR) spectroscopy / Andrew Philips; title: Mechanism and processing parameters affecting the formation of sulfonate esters : summary of the PQRI studies : PQRI working group / Andrew Teasdale; title: 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.