The mammalian in vivo micronucleus test detects damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals.

The mammalian in vivo micronucleus test is used for the detection of damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals, usually rodents (mice or rats).

The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters).

This Test Guideline describes an in vivo erythrocyte Pig-a gene mutation assay (hereafter called the Pig-a assay) which uses an endogenous mammalian gene, the phosphatidylinositol glycan class A gene (Pig-a), as a reporter of somatic-cell gene mutation. In vivo gene mutation tests, such as the Pig-a assay, are especially relevant for assessing mutagenicity because physiological factors, such as absorption of the test chemical from the site of exposure, distribution of the test chemical throughout the test system via systemic circulation, and in vivo metabolism and DNA repair processes, all contribute to the mutagenic responses.

Following a general update of the Genetic Toxicology TGs in 2015, the present Document was written to provide succinct and useful information to individuals unfamiliar with genetic toxicology testing, as well as experienced individuals wishing to obtain an overview of the recent changes that ...

Concerns about the adverse health effects of chemicals and radiation present in the environment and at workplaces have created the need for better detection systems to assess their potential to cause DNA damage in humans and other organisms across ecosystems. The Micronucleus Assay in Toxicology is the first comprehensive volume concerning the use of micronucleus assays in genetic toxicology. It succinctly explains the mechanisms by which genotoxins cause micronucleus formation and its relation to diseases. Furthermore, it describes the methods which are currently used for the analyses of micronuclei in different types of cells in human in vivo biomonitoring studies, routine in vivo tests with rodents, in vitro studies with human and mammalian cells, environmental monitoring with invertebrates and vertebrates such as molluscs, fish and, also, in plant bioassays. Moreover, this book also focuses on the use of the micronucleus technique in other research areas, including the detection of DNA damage caused by important groups of genotoxic carcinogens (heavy metals, industrial chemicals, cytotoxic drugs, pesticides, ionising radiation, etc.) as well as study designs, statistical analyses, international regulatory guidelines, and the development of automated scoring devices for this assay. This book will serve as both, a reference and a guide to students, and investigators in biomedical, biochemical and pharmaceutical sciences interested in gaining a better understanding of the biology of micronuclei and their application in measuring DNA damage caused by natural or man-made genotoxins.

Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author's training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect biomarkers. Each chapter contains several references to current literature and important resources for further reading. Given this comprehensive treatment, this book is an essential reference for anyone interested in biomarkers across the scientific and biomedical fields. - Evaluates the expansive literature, providing one resource covering all aspects of toxicology biomarkers - Includes completely revised chapters, along with additional chapters on the newest developments in the field - Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure - Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation, and much more

Toxicodynamics in Drug Research, Volume 2: Public Health and Toxicology Issues examines the implications of public health issues and the impact of pharmaceuticals, chemical and food toxicants, dietary phytochemicals, and medical treatments on human health. Volume 2: Public Health and Toxicology Issues in Drug Research: Toxicity and Toxicodynamics covers topics on pharmacokinetics and toxicokinetics such as population pharmacokinetics/toxicokinetics, the design of toxicokinetic studies, and the use of toxicokinetic data in preclinical safety assessments. The book investigates the health effect caused by the bioaccumulation of pharmaceutical and personal care products and the impact of drug-induced toxicity on different systems of the body. It discusses the mechanistic pathways of food toxicants and illustrates the molecular mechanisms of the chemopreventive role of dietary phytochemicals. It also delves into the toxic effects of medical treatments and materials. Ethical, legal, societal, and professional issues in toxicology round off the coverage providing a valuable resource to interested in learning more about the health impact and public health issues related to the toxicity of pharmaceuticals, dietary supplements, personal care products, and medical treatments. - Discusses the impact of pharmaceuticals, food, and chemical toxicants on human health - Examines the toxic effects of medical treatments, clinical administrations, and materials - Explores public health issues around drug safety and toxicology