Author: OECD
Publisher: OECD Publishing
ISBN: 9264274715
Category :
Languages : en
Pages : 148
Book Description
This scoping document aims at bringing forward relevant in vitro and ex vivo thyroid assays to the attention of OECD member countries, to provide recommendations for their development/use, and also, to identify aspects/blocks of the thyroid signalling pathways that are not covered and would ...
OECD Series on Testing and Assessment New Scoping Document on in vitro and ex vivo Assays for the Identification of Modulators of Thyroid Hormone Signalling
OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption
Author: OECD
Publisher: OECD Publishing
ISBN: 9264304746
Category :
Languages : en
Pages : 692
Book Description
This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.
Publisher: OECD Publishing
ISBN: 9264304746
Category :
Languages : en
Pages : 692
Book Description
This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.
OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods
Author: OECD
Publisher: OECD Publishing
ISBN: 9264274731
Category :
Languages : en
Pages : 17
Book Description
The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether ...
Publisher: OECD Publishing
ISBN: 9264274731
Category :
Languages : en
Pages : 17
Book Description
The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether ...
Endocrine Disruption and Human Health
Author: Philippa D. Darbre
Publisher: Academic Press
ISBN: 0128219882
Category : Medical
Languages : en
Pages : 536
Book Description
**Selected for Doody's Core Titles® 2024 in Endocrinology/Metabolic Disease** Updated with new and expanded chapters, Endocrine Disruption and Human Health, Second Edition provides an introduction to what endocrine disruptors are, the issues surrounding them, the source of these chemicals in the ecosystem and the mechanisms of action and assay systems. Contributions by specialists are included to discuss the varying effects of endocrine disruption on human health, and procedures for risk assessment of endocrine disruptors, and current approaches to their regulation are also covered. With new material on topics such as low-term, low dose mixtures, windows of susceptibility, epigenetics, EDCs effect on the gut microbiome, EDCs in from polluted air and oral exposures, green chemistry, and nanotechnology, the new edition of Endocrine Disruption and Human Health is a valuable and informative text for academic and clinical researchers and other health professionals approaching endocrine disruption and its effects on human health for the first time, graduate students, and advanced undergraduate students. - Provides readers with access to a range of information from the basic mechanisms and assays through to cutting-edge research investigating concerns for human health - Presents a comprehensive, translational look at all aspects of endocrine disruption and its effects on human health - Offers guidance on the risk assessment of endocrine disruptors and current relevant regulatory considerations - Newly added content on topics like low-term, low dose mixtures, windows of susceptibility to EDCs, EDCs effect on the gut microbiome, green chemistry, and nanotechnology
Publisher: Academic Press
ISBN: 0128219882
Category : Medical
Languages : en
Pages : 536
Book Description
**Selected for Doody's Core Titles® 2024 in Endocrinology/Metabolic Disease** Updated with new and expanded chapters, Endocrine Disruption and Human Health, Second Edition provides an introduction to what endocrine disruptors are, the issues surrounding them, the source of these chemicals in the ecosystem and the mechanisms of action and assay systems. Contributions by specialists are included to discuss the varying effects of endocrine disruption on human health, and procedures for risk assessment of endocrine disruptors, and current approaches to their regulation are also covered. With new material on topics such as low-term, low dose mixtures, windows of susceptibility, epigenetics, EDCs effect on the gut microbiome, EDCs in from polluted air and oral exposures, green chemistry, and nanotechnology, the new edition of Endocrine Disruption and Human Health is a valuable and informative text for academic and clinical researchers and other health professionals approaching endocrine disruption and its effects on human health for the first time, graduate students, and advanced undergraduate students. - Provides readers with access to a range of information from the basic mechanisms and assays through to cutting-edge research investigating concerns for human health - Presents a comprehensive, translational look at all aspects of endocrine disruption and its effects on human health - Offers guidance on the risk assessment of endocrine disruptors and current relevant regulatory considerations - Newly added content on topics like low-term, low dose mixtures, windows of susceptibility to EDCs, EDCs effect on the gut microbiome, green chemistry, and nanotechnology
Toxicology and Risk Assessment
Author: Helmut Greim
Publisher: John Wiley & Sons
ISBN: 1119135915
Category : Science
Languages : en
Pages : 838
Book Description
Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.
Publisher: John Wiley & Sons
ISBN: 1119135915
Category : Science
Languages : en
Pages : 838
Book Description
Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.
Hayes' Principles and Methods of Toxicology
Author: A. Wallace Hayes
Publisher: CRC Press
ISBN: 1000875776
Category : Medical
Languages : en
Pages : 2143
Book Description
Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.
Publisher: CRC Press
ISBN: 1000875776
Category : Medical
Languages : en
Pages : 2143
Book Description
Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.
Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Author: Franz J. Hock
Publisher: Springer Nature
ISBN: 3031355296
Category : Medical
Languages : en
Pages : 2751
Book Description
Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.
Publisher: Springer Nature
ISBN: 3031355296
Category : Medical
Languages : en
Pages : 2751
Book Description
Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.
Toxicology for the Health and Pharmaceutical Sciences
Author: Antonio Peña-Fernández
Publisher: CRC Press
ISBN: 1351398016
Category : Medical
Languages : en
Pages : 531
Book Description
There is an increasing need for knowledge of toxicology to safeguard the use of chemicals in industry and in the public and private sectors. The study of toxicology is becoming increasingly relevant in human health sciences, as future health and clinical professionals will be pivotal in addressing and managing emerging chemical threats and hazards related to modern anthropogenic activities and technological development. Comprising a series of chapters from leading toxicology, pharmacy and public health academics and experts across Europe, the United States and beyond, Toxicology for the Health and Pharmaceutical Sciences provides a concise yet comprehensive volume that can be used as a relevant textbook on toxicology for the clinical, healthcare, educational and professional sectors. Key Features: Includes cutting edge information regarding the very lastest environmental threats to public health Provides a detailed case study based on a real-world scenario that allows the reader to practice human health risk assessment Describes innovative guidance and tools to respond to chemical incidents and attacks, which enables the reader to tailor an effective protection and remediation response This book covers the fundamentals and recent developments in toxicology, to respond to local and global chemical, pharmaceutical and environmental threats. Thus, this volume has chapters specifically designed to support the understanding of the most current toxicology-related subjects for any undergraduate/postgraduate health programs as well as aid the delivery of continuing professional development training on up-to-date topics in toxicology for current practicing health professionals wishing to improve their background knowledge in toxicology. The book is also vital reading and reference for policy makers and others that influence and set regulations that have an impact on the environment and human health.
Publisher: CRC Press
ISBN: 1351398016
Category : Medical
Languages : en
Pages : 531
Book Description
There is an increasing need for knowledge of toxicology to safeguard the use of chemicals in industry and in the public and private sectors. The study of toxicology is becoming increasingly relevant in human health sciences, as future health and clinical professionals will be pivotal in addressing and managing emerging chemical threats and hazards related to modern anthropogenic activities and technological development. Comprising a series of chapters from leading toxicology, pharmacy and public health academics and experts across Europe, the United States and beyond, Toxicology for the Health and Pharmaceutical Sciences provides a concise yet comprehensive volume that can be used as a relevant textbook on toxicology for the clinical, healthcare, educational and professional sectors. Key Features: Includes cutting edge information regarding the very lastest environmental threats to public health Provides a detailed case study based on a real-world scenario that allows the reader to practice human health risk assessment Describes innovative guidance and tools to respond to chemical incidents and attacks, which enables the reader to tailor an effective protection and remediation response This book covers the fundamentals and recent developments in toxicology, to respond to local and global chemical, pharmaceutical and environmental threats. Thus, this volume has chapters specifically designed to support the understanding of the most current toxicology-related subjects for any undergraduate/postgraduate health programs as well as aid the delivery of continuing professional development training on up-to-date topics in toxicology for current practicing health professionals wishing to improve their background knowledge in toxicology. The book is also vital reading and reference for policy makers and others that influence and set regulations that have an impact on the environment and human health.
European Partnership on the Assessment of Risks from Chemicals (PARC): Focus on New Approach Methodologies (NAMs) in Risk Assessment
Author: Terje Svingen
Publisher: Frontiers Media SA
ISBN: 2832553389
Category : Medical
Languages : en
Pages : 125
Book Description
The European Partnership on the Assessment of Risks from Chemicals (PARC) project was launched in 2022. The overarching aim of this partnership is to enhance our knowledge about chemical substances to better safeguard human health and the environment against harmful effects. The project will run for seven years under Horizon Europe. PARC is subdivided into several work packages (WPs). WP5 is focused on hazard assessment for human and environmental health and includes more than 80 partners across Europe. WP5 aims to fill data gaps for specified chemical substances of concern (e.g, bisphenol alternatives) and to develop or improve new approach methodologies (NAMs) for chemical hazard assessment. This is in order to progress towards a risk assessment paradigm relying less on animal toxicity data, both with respect to human health and environmental safety. As the PARC initiative will evolve over time with respect to both projects and activities, presenting early initiatives will foster an increased awareness of ongoing activities and potential incorporation of new activities going forward.
Publisher: Frontiers Media SA
ISBN: 2832553389
Category : Medical
Languages : en
Pages : 125
Book Description
The European Partnership on the Assessment of Risks from Chemicals (PARC) project was launched in 2022. The overarching aim of this partnership is to enhance our knowledge about chemical substances to better safeguard human health and the environment against harmful effects. The project will run for seven years under Horizon Europe. PARC is subdivided into several work packages (WPs). WP5 is focused on hazard assessment for human and environmental health and includes more than 80 partners across Europe. WP5 aims to fill data gaps for specified chemical substances of concern (e.g, bisphenol alternatives) and to develop or improve new approach methodologies (NAMs) for chemical hazard assessment. This is in order to progress towards a risk assessment paradigm relying less on animal toxicity data, both with respect to human health and environmental safety. As the PARC initiative will evolve over time with respect to both projects and activities, presenting early initiatives will foster an increased awareness of ongoing activities and potential incorporation of new activities going forward.
Test No. 421: Reproduction/Developmental Toxicity Screening Test
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070966
Category :
Languages : en
Pages : 10
Book Description
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...
Publisher: OECD Publishing
ISBN: 9264070966
Category :
Languages : en
Pages : 10
Book Description
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...