TY  - BOOK
AU  - Teasdale,Andrew
TI  - Genotoxic impurities: strategies for identification and control 
SN  - 9780470929360
AV  - RA1224.3 .G463 2010eb
U1  - 616/.042 22
PY  - 2010///
CY  - Hoboken, N.J.
PB  - Wiley
KW  - Genetic toxicology
KW  - Drugs
KW  - Toxicology
KW  - Mutagenicity Tests
KW  - methods
KW  - Drug Toxicity
KW  - prevention & control
KW  - Mutagens
KW  - adverse effects
KW  - analysis
KW  - Toxicogenetics
KW  - HEALTH & FITNESS
KW  - Diseases
KW  - Genetic
KW  - bisacsh
KW  - MEDICAL
KW  - Genetics
KW  - fast
KW  - Electronic books
N1  - 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. 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 [and others] -- 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 [and others] -- 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
N2  - This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. T
UR  - http://onlinelibrary.wiley.com/book/10.1002/9780470929377
ER  -