Coverart for item
The Resource Genotoxic impurities : strategies for identification and control, edited by Andrew Teasdale, (electronic resource)

Genotoxic impurities : strategies for identification and control, edited by Andrew Teasdale, (electronic resource)

Label
Genotoxic impurities : strategies for identification and control
Title
Genotoxic impurities
Title remainder
strategies for identification and control
Statement of responsibility
edited by Andrew Teasdale
Contributor
Subject
Language
eng
Summary
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
Dewey number
616/.042
Illustrations
illustrations
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
Teasdale, Andrew
http://library.link/vocab/subjectName
  • Genetic toxicology
  • Drugs
  • Mutagenicity Tests
  • Drug Toxicity
  • Mutagens
  • Mutagens
  • Toxicogenetics
Label
Genotoxic impurities : strategies for identification and control, edited by Andrew Teasdale, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Color
mixed
Contents
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
Control code
ocn698591455
Dimensions
unknown
Extent
1 online resource (xii, 428 p.)
Form of item
online
Isbn
9780470929360
Isbn Type
(electronic bk.)
Note
Wiley
Other control number
10.1002/9780470929377
Other physical details
ill
Specific material designation
remote
System control number
(OCoLC)698591455
Label
Genotoxic impurities : strategies for identification and control, edited by Andrew Teasdale, (electronic resource)
Publication
Bibliography note
Includes bibliographical references and index
Color
mixed
Contents
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
Control code
ocn698591455
Dimensions
unknown
Extent
1 online resource (xii, 428 p.)
Form of item
online
Isbn
9780470929360
Isbn Type
(electronic bk.)
Note
Wiley
Other control number
10.1002/9780470929377
Other physical details
ill
Specific material designation
remote
System control number
(OCoLC)698591455

Library Locations

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