Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

QSAR in Safety Evaluation and Risk Assessment provides comprehensive coverage on QSAR methods, tools, data sources, and models focusing on applications in products safety evaluation and chemicals risk assessment. Organized into five parts, the book covers almost all aspects of QSAR modeling and application. Topics in the book include methods of QSAR, from both scientific and regulatory viewpoints; data sources available for facilitating QSAR models development; software tools for QSAR development; and QSAR models developed for assisting safety evaluation and risk assessment. Chapter contributors are authored by a lineup of active scientists in this field. The chapters not only provide professional level technical summarizations but also cover introductory descriptions for all aspects of QSAR for safety evaluation and risk assessment. - Provides comprehensive content about the QSAR techniques and models in facilitating the safety evaluation of drugs and consumer products and risk assesment of environmental chemicals - Includes some of the most cutting-edge methodologies such as deep learning and machine learning for QSAR - Offers detailed procedures of modeling and provides examples of each model's application in real practice

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.

This book is a collection of the papers presented at a symposium on the topic. The papers examine the chemistry of N-nitroso compounds, the "in-vivo" reactions of the compounds, metabolic activation, and detection of the compounds.

Reproductive toxicology is a complex subject dealing with three components—parent, placenta, and fetus—and the continuous changes that occur in each. Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science. It addresses a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, food additives, nutraceuticals and pharmaceuticals, and metals, among others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, and is the only resource to include reproductive and developmental toxicity in domestic animals, fish, and wildlife. - Provides a complete, integrated source of information on the key risk stages during reproduction and development - Includes coverage of emerging science such as stem cell application, toxicoproteomics, metabolomics, phthalates, infertility, teratogenicity, endocrine disruption, surveillance and regulatory considerations, and risk assessment - Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis

Exposure to a wide variety of chemicals and drugs has become common in industrial, laboratory, and even household environments. Fortunately, global understanding and consequently global safety standards regarding the management of toxic and hazardous substances are fast approaching uniformity. The methods of handling, use, transportation, storage, and disposal in particular are moving toward standardization. As these protocols involving chemicals and drugs continue to cross international borders, students and professionals need a reliable resource to ensure they observe appropriate safety standards. The Industrial Guide to Chemical and Drug Safety covers not only current standards, but also a wealth of information on toxins to help regulatory bodies develop new protocols. Written in an accessible narrative style, the Guide covers chemicals by key classes such as solvents, pesticides, and metals, and also by key industries such as drugs, food additives, plastics, cosmetics, detergents, and soaps. The book explains the beneficial and harmful aspects of a broad range of materials to which students, trainees, skilled workers, managers, and personnel associated with regulatory agencies are exposed, with the purpose of helping them avoid the illnesses associated with the misuse of chemicals and drugs. Chapters include: -Heavy Metals -Pesticides -Industrial Solvents -Industrial Gases and Fumes -Drugs -Target Organ Toxicity -Disposal of Hazardous Chemicals -Guidance to Students and Workers -Good Laboratory Practice