A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Toxicology studies are carried out on all drug substances to ensure safety. This book provides an overview of the methodology andrequirements of pre-clinical safety assessments of new medicines. with the focus on medicinal drugs - the most important safety issues of drugs are covered, including registration requirements of new drugs and pharmacovigilance. This is an introductory text for students at BSc, MSc and PhD levels,and will be an excellent companion to pharmacology textbooks, combining a broad treatment of the issues relevant for assessing the safety/efficacy balance of a new drug wit

This book provides a broad reference covering important drugs of abuse including amphetamines, opiates, and steroids. It also covers psychoactive plants such as caffeine, peyote, and psilocybin. It provides chemical structures, analytical methods, clinical features, and treatments of these drugs of abuse, serving as a highly useful, in-depth supplement to a general medical toxicology book. The style allows for the easy application of the contents to searchable databases and other electronic products, making this an essential resource for practitioners in medical toxicology, industrial hygiene, occupational medicine, pharmaceuticals, environmental organizations, pathology, and related fields.

Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. - Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development - New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies - Details IPR issues of translation, especially for public-private-partnerships - Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

"There is an increasing need for knowledge of toxicology to safeguard the use of chemicals in industry, public and private sectors. The study of toxicology is becoming increasingly relevant in human health sciences, as future health and clinical professionals will be pivotal to address and manage emerging chemical threats and hazards related to modern anthropogenic activities and technological development. Comprising a series of chapters from leading toxicology, pharmacy and public health academics and experts across Europe, the United States and beyond, Toxicology for the Health and Pharmaceutical Sciences provides a concise yet comprehensive volume that can be used as a relevant textbook on toxicology for the clinical, healthcare, educational and professional sectors. This book covers the fundamentals and recent developments in toxicology, to respond to local and global chemical, pharmaceutical and environmental threats. Thus, this volume has chapters specifically designed to support the understanding of the most current, toxicology-related subjects for any undergraduate/postgraduate health programmes, as well as aiding with the delivery of continuing professional development training on up-to-date topics in toxicology for current practicing health professionals wishing to improve their background knowledge in toxicology. The book is also vital reading, and reference for policy makers, and others that influence, and decide regulations that have an impact on the environment, and human health"--

This invaluable textbook, written by international experts, covers all the main elements of forensic toxicology and analytical toxicology techniques as well as the important parts of pharmacokinetics, drug metabolism, and pharmacology in general, with a particular focus on drugs of abuse.