This updated and revised edition delineates the basic concepts and fundamental principles needed to grasp current issues in modern toxicology. In addition, new contributions help to redefine the book's scope and coverage, and illuminate new and emerging areas of toxicologic interest.

Toxicology begins from basic research investigations on the mechanism of action of toxins through the development and interpretation of standard tests characterizing the toxic properties of agents. Toxicology provides important tools for both medicine and epidemiology in understanding aetiology and in providing information as to the plausibility of observed associations between exposures, including occupations, and disease. Toxicology can be divided into various disciplines, such as clinical, forensic, investigative and regulatory toxicology; toxicology can be considered by target organ system or process, such as immunotoxicology or genetic toxicology; toxicology can be presented in functional terms, such as research, testing and risk assessment. Today, toxicology has become an important element in environmental and occupational health. As part of prevention strategies, toxicology is invaluable, since it is the source of information on potential hazards in the absence of widespread human exposures. Toxicological screening are also widely used by industry, academic in product development, to provide information useful in the design of specific molecules or product formulations.

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.