Toxicological Risk Assessment and Multisystem Health Impacts From Exposure highlights the emerging problems of human and environmental health attributable to cumulative and multiple sources of long-term exposure to environmental toxicants. The book describes the cellular, biological, immunological, endocrinologic, genetic, and epigenetic effects of long-term exposure. It examines how the combined exposure to nanomaterials, metals, pharmaceuticals, multifrequency radiation, dietary mycotoxins, and pesticides accelerates ecotoxicity in humans, animals, plants, and the larger environment. The book goes on to also offer insights into mixture risk assessments, protocols for evaluating the risks, and how this information can serve the regulatory agencies in setting safer exposure limits. The book is a go-to resource for scientists and professionals in the field tackling the current and emerging trends in modern toxicology and risk assessment. - Bridges basic research with clinical, epidemiological, regulatory, and translational research, conveying both an introductory understanding and the latest developments in the field - Evaluates real-life human health risk assessment for long-term exposures to xenobiotic mixtures and the role they play in contributing to chronic disease - Discusses advances in predictive (in silico) toxicology tools and the benefits of using omics technologies in toxicology research

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology

As technology continues to evolve at an unprecedented pace, the field of auditing is also undergoing a significant transformation. Traditional practices are being challenged by the complexities of modern business environments and the integration of advanced technologies. This shift requires a new approach to risk assessment and auditing, one that can adapt to the changing landscape and address the emerging challenges of technology-driven organizations. Advances in Enterprise Technology Risk Assessment offers a comprehensive resource to meet this need. The book combines research-based insights with actionable strategies and covers a wide range of topics from the integration of unprecedented technologies to the impact of global events on auditing practices. By balancing both theoretical and practical perspectives, it provides a roadmap for navigating the intricacies of technology auditing and organizational resilience in the next era of 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.