Statistical Evaluation of Mutagenicity Test Data PDF Download
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Author: David J. Kirkland
Publisher: Cambridge University Press
ISBN: 9780521048149
Category : Medical
Languages : en
Pages : 316
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Book Description
This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds.
Author: David J. Kirkland
Publisher: Cambridge University Press
ISBN: 9780521048149
Category : Medical
Languages : en
Pages : 316
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Book Description
This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds.
Author: David J. Kirkland
Publisher: Cambridge University Press
ISBN: 9780521393478
Category : Medical
Languages : en
Pages : 164
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Book Description
A summary of the essential texts that must be performed on all new compounds before they can be registered for use in the UK.
Author:
Publisher:
ISBN:
Category : Mutagenicity testing
Languages : en
Pages : 294
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Book Description
Author: United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing
Publisher: Cambridge University Press
ISBN: 052145073X
Category : Medical
Languages : en
Pages : 179
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Book Description
Originally published in 1993, this volume describes supplementary tests used to assess risks of in vitro mutagenicity when basic safety tests were inconclusive.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264071245
Category :
Languages : en
Pages : 12
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Book Description
The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ...
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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Book Description
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Author: Ludwig Hothorn
Publisher: Springer Science & Business Media
ISBN: 364248736X
Category : Medical
Languages : en
Pages : 158
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Book Description
This book contains selected papers from a workshop on modern statistical methods in toxicology held during the EUROTOX '90 conference in Leipzig. The papers deal with the biostatistical evaluation of the commonly used toxicological assays, i.e. mutagenicity, long-term carcinogenicity, embryotoxicity and chronic toxicity assays. The biological background is considered in detail, and most of the related statistical approaches described. In five overview papers, the present state of the art of the related topics is given, while in several contributed papers new approaches are discussed. The most important features are: - A new view on the per-litter analysis problem in em- bryotoxicity assays. - A highly sophisticated treatment of the so-called muta-tox problem in mutagenicity assays. - A detailed discussion of the multiplicity problem based on the closed testing procedure. This volume provides readers with an overview of modern biostatistical methods for several toxicological assays and is in part intended for direct, practical use.
Author:
Publisher:
ISBN:
Category : Biometry
Languages : en
Pages : 320
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Book Description
Author: Byron J. T. Morgan
Publisher: Oxford University Press
ISBN: 9780198523291
Category : Mathematics
Languages : en
Pages : 250
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Book Description
This collection of papers on aspects of statistics in toxicology is will be of interest to all medical statisticians. It offers findings from numerous leading experts from around the world including A. Whitehead and R. N. Connor (University of Reading), L. Ryan (Harvard), A. P. Grieve (Pfizer Research), K.J. Risko (Northern Telecom), and B.H. Margolin (University of North Carolina). This is the latest in the popular Royal Statistical Society Lecture Series, and will be essential reading for all those involved in this area.
Author: S. Venitt
Publisher:
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 378
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Book Description
LABORATORY MANUAL. GENETIC TOXICOLOGY. BACTERIA. YEAST. FRUIT FLY. CULTURED MAMMALIAN CELLS. CYTOGENETIC TESTING. RODENTS. DOMINANT LETHAL TEST.
