Author: Ludwig Hothorn
Publisher: Springer Science & Business Media
ISBN: 364248736X
Category : Medical
Languages : en
Pages : 158
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.
Statistical Methods in Toxicology
Author: Ludwig Hothorn
Publisher: Springer Science & Business Media
ISBN: 364248736X
Category : Medical
Languages : en
Pages : 158
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.
Publisher: Springer Science & Business Media
ISBN: 364248736X
Category : Medical
Languages : en
Pages : 158
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.
Basic Mutagenicity Tests
Author: David J. Kirkland
Publisher: Cambridge University Press
ISBN: 9780521393478
Category : Medical
Languages : en
Pages : 164
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.
Publisher: Cambridge University Press
ISBN: 9780521393478
Category : Medical
Languages : en
Pages : 164
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.
Mutagenic Impurities
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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.
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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.
Environmental Health Perspectives
Author:
Publisher:
ISBN:
Category : Environmental health
Languages : en
Pages : 1162
Book Description
Publisher:
ISBN:
Category : Environmental health
Languages : en
Pages : 1162
Book Description
Handbook of Carcinogenic Potency and Genotoxicity Databases
Author: Lois Swirsky Gold
Publisher: CRC Press
ISBN: 9781439810644
Category : Medical
Languages : en
Pages : 840
Book Description
This unique new reference contains the Carcinogenic Potency Database (CPDB), which analyzes results of decades of animal cancer tests, including all Technical Reports of the National Toxicology Program (NTP) and the general published literature. A guide to the literature of animal cancer tests, the CPDB includes references to each published experiment and never-before published analyses. For each of 5,000 long-term experiments on 1,300 chemicals, the user-friendly format includes data on the species, strain, and sex of the test animal; features of experimental protocol such as the route of administration, duration of dosing, dose levels, and duration of the experiment; histopathology and tumor incidence; the shape of the dose-response curve; published author's opinion about the carcinogenicity at each site; and reference to the original publication of the test results. In addition, a measure of carcinogenic potency, the TD50, its statistical significance and confidence limits, are given for each tumor site. An overview is provided of earlier publication updates, such as positivity rates, reproducibility, interspecies extrapolation, and ranking possible carcinogenic hazards. The book also includes a summary of the NTP genetic toxicity test results on 1,500 chemicals, which are referenced to the original publications, including the Salmonella (Ames) test, L5178Y mouse lymphoma cell mutation test, chromosome aberration and sister chromatid exchange tests in cultured Chinese hamster ovary cells, and the sex-linked recessive lethal mutation test in Drosophila melanogaster. An index with chemicals listed by CAS number allows cross referencing between the carcinogenicity and genotoxicity databases, making data easy to find.
Publisher: CRC Press
ISBN: 9781439810644
Category : Medical
Languages : en
Pages : 840
Book Description
This unique new reference contains the Carcinogenic Potency Database (CPDB), which analyzes results of decades of animal cancer tests, including all Technical Reports of the National Toxicology Program (NTP) and the general published literature. A guide to the literature of animal cancer tests, the CPDB includes references to each published experiment and never-before published analyses. For each of 5,000 long-term experiments on 1,300 chemicals, the user-friendly format includes data on the species, strain, and sex of the test animal; features of experimental protocol such as the route of administration, duration of dosing, dose levels, and duration of the experiment; histopathology and tumor incidence; the shape of the dose-response curve; published author's opinion about the carcinogenicity at each site; and reference to the original publication of the test results. In addition, a measure of carcinogenic potency, the TD50, its statistical significance and confidence limits, are given for each tumor site. An overview is provided of earlier publication updates, such as positivity rates, reproducibility, interspecies extrapolation, and ranking possible carcinogenic hazards. The book also includes a summary of the NTP genetic toxicity test results on 1,500 chemicals, which are referenced to the original publications, including the Salmonella (Ames) test, L5178Y mouse lymphoma cell mutation test, chromosome aberration and sister chromatid exchange tests in cultured Chinese hamster ovary cells, and the sex-linked recessive lethal mutation test in Drosophila melanogaster. An index with chemicals listed by CAS number allows cross referencing between the carcinogenicity and genotoxicity databases, making data easy to find.
Genetic Toxicology Testing
Author: Ray Proudlock
Publisher: Academic Press
ISBN: 0128010061
Category : Medical
Languages : en
Pages : 458
Book Description
Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. - Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab - Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results - Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) - Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab
Publisher: Academic Press
ISBN: 0128010061
Category : Medical
Languages : en
Pages : 458
Book Description
Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. - Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab - Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results - Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) - Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab
Some Chemicals Present in Industrial and Consumer Products, Food and Drinking-water
Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: IARC Monographs on the Evaluat
ISBN: 9789283213246
Category : Medical
Languages : en
Pages : 0
Book Description
This volume of the IARC Monographs provides an assessment of the carcinogenicity of 18 chemicals present in industrial and consumer products or food (natural constituents, contaminants, or flavorings) or occurring as water-chlorination by-products. The compounds evaluated include the widely used plasticizer di(2-ethylhexyl) phthalate and the food contaminant 4-methylimidazole. In view of the limited agent-specific information available from epidemiological studies, the IARC Monographs Working Group relied mainly on carcinogenicity bioassays, and mechanistic and other relevant data to evaluate the carcinogenic hazards to humans exposed to these agents.
Publisher: IARC Monographs on the Evaluat
ISBN: 9789283213246
Category : Medical
Languages : en
Pages : 0
Book Description
This volume of the IARC Monographs provides an assessment of the carcinogenicity of 18 chemicals present in industrial and consumer products or food (natural constituents, contaminants, or flavorings) or occurring as water-chlorination by-products. The compounds evaluated include the widely used plasticizer di(2-ethylhexyl) phthalate and the food contaminant 4-methylimidazole. In view of the limited agent-specific information available from epidemiological studies, the IARC Monographs Working Group relied mainly on carcinogenicity bioassays, and mechanistic and other relevant data to evaluate the carcinogenic hazards to humans exposed to these agents.
Mutagenicity Testing
Author: S. Venitt
Publisher:
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 378
Book Description
LABORATORY MANUAL. GENETIC TOXICOLOGY. BACTERIA. YEAST. FRUIT FLY. CULTURED MAMMALIAN CELLS. CYTOGENETIC TESTING. RODENTS. DOMINANT LETHAL TEST.
Publisher:
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 378
Book Description
LABORATORY MANUAL. GENETIC TOXICOLOGY. BACTERIA. YEAST. FRUIT FLY. CULTURED MAMMALIAN CELLS. CYTOGENETIC TESTING. RODENTS. DOMINANT LETHAL TEST.
Genotoxic Impurities
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455
Book Description
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. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455
Book Description
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. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Toxicological Profile for Nitrophenols
Author:
Publisher:
ISBN:
Category : Nitro compounds
Languages : en
Pages : 136
Book Description
Publisher:
ISBN:
Category : Nitro compounds
Languages : en
Pages : 136
Book Description