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The compilation of this book was prompted by the necessity of a bench volume which could provide the necessary background information on materials, experimental design, pitfalls and dificulties, in order to perform a particular test in an acceptable way with a minimal need for additional expert help. This Second Edition updates this information, providing: - a comprehensive bench guide - methods known to be reliable - a broad spectrum of approaches - tips to avoid pitfalls when using unfamiliar techniques - data from population records - safety aspects of mutagens and carcinogens - basic statistical concepts for experiment design This `on the bench' methodological text provides the necessary information for most of the common assays for genetic damage in use. The book includes methods which have been sufficiently used and tested to make their use reliable, but also presents methods which are not widely used at present, but which might prove most useful in screening for mutagenic effects.
A summary of the essential texts that must be performed on all new compounds before they can be registered for use in the UK.
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.
Topics in Toxicology Toxicology is a science that stands at the intersection of several interests and disciplines. These intersecting forces are by no means all scientific since some are legal and some are commercial. All have valid things to say about the conduct and interpretation of toxicity experiments. The practising toxicologist must bear all these sometimes conflicting forces in mind as he carries out his duties. This is especially true, of course, of the toxicologist in industry. Toxicology is also a field in which contract research particularly flourishes and a number of major contract research companies have established over the years a reputation for contributing usefully to the practice of this skill. These contract research organisations are particu larly favoured to develop an appreciation of the problems of the industrial toxicologist, since it is very common for such a company to service the toxicological needs of companies in several sectors of industry producing new chemical compounds, and the contract research company, therefore, is aware of a wider diversity of problems than probably affects a single toxicologist in one industry.
The varying cancer incidence from country to country and region to region suggests that en vironmental factors play a considerable role in the aetiology of cancer. Whether these factors in the environment moderate the effect of car cinogenic chemicals or whether they might them selves be carcinogenic is not known at the present time. What is known is that there are various chemicals, both naturally occurring and man-made, which can induce cancer in man. In the Western world estimates vary as to how much cancer is occupational in origin; the figures range from 1% to 40%. It is our feeling that probably about 10% of cancer has a direct oc cupational origin. Nevertheless this number is considerable and it behoves us therefore to identify those chemicals which are carcinogenic and to reduce human exposure. Recent work on the mode of action of carcinogenic chemicals suggests that the majority exert their effect through an activation step to give elec trophilic metabolites. Such metabolites have as a common feature the ability to react with cel lular nucleophiles to give covalently bound products. Such reaction will occur after carcino gen treatment of animals with nucleic acids par ticularly in target organs. It is reaction with nucleic acids that provides the basis of a num ber of short-term tests for carcinogens, since the basic composition of DNA is similar in micro-organisms and in human cells.
Bioassays are among the ecotoxicologist's most effective weapons in the evaluation of water quality and the assessment of ecological impacts of effluents, chemicals, discharges, and emissions on the aquatic environment. Information on these assessment aids is needed throughout the international scientific and environmental management community. This comprehensive reference provides an excellent overview of the small-scale aquatic bioassay techniques and applications currently in use around the world. This special volume is the result of several years of collaboration between Environment Canada and Fisheries and Oceans Canada. Internationally recognized research scientists at many institutions have contributed to this state-of-the-art examination of the exciting, environmentally important field of microscale testing in aquatic toxicology. Microscale Testing in Aquatic Toxicology contains over forty chapters covering relevant principles, new techniques and recent advancements, and applications in scientific research, environmental management, academia, and the private sector.
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
Mammalian Toxicology surveys chemical agents and examineshow such chemicals impact on human health, emphasizing theimportance in minimizing environmental exposure to chemical andphysical hazards in our homes, communities and workplaces throughsuch media as contaminated water, soil and air. Starting with the basic principles on a wide range of toxicagents, this textbook describes how they enter the body, theirmechanisms of action once inside, and strategies for diagnosis,prevention and treatment. Topics covered include: General principles of toxicology: pharmacological andtoxicological principles underpinning the study of toxicology, risk assessments and mechanisms of cell death Disposition: routes of chemical exposures, entry intothe body and various tissues, storage, metabolic biotransformationand elimination, with examples from various toxicants. Toxic agents: the occurrences, disposition in the body,health effects, toxic mechanisms, antidotes and treatments of arange of agents including pesticides, metals, solvents, gases,nanomaterials, food components and additives, pharmaceuticals,drugs of abuse, natural toxins, endocrine disruptors, radiation,and warfare weapons. Toxic effects: including neurotoxicity, developmentaltoxicity, immunotoxicity, teratogenecity, male and femalereproductive toxicity, mutagenecity, carcinogenicity, pulmonary toxicity, cardiovascular toxicity, hepatotoxicity,gastrointestinal toxicity and cardiovascular toxicity Toxicology and society: epidemiological studies ofchemical-induced diseases in human populations, and a vision fortoxicology in the 21st century. Mammalian Toxicology is an essential primer for studentsof toxicology, biochemistry, biology, medicine and chemistry. It isalso appropriate for professional toxicologists in research orregulatory affairs, and anyone who needs to understand the adverseeffects of toxic agents on the human body.