A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more - Updated with 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 the expectations associated with working in nonclinical toxicology

The apparent contradiction between statistical significance and biological relevance has diminished the value of statistical methods as a whole in toxicology. Moreover, recommendations for statistical analysis are imprecise in most toxicological guidelines. Addressing these dilemmas, Statistics in Toxicology Using R explains the statistical analysi

Statistics for Environmental Biology and Toxicology presents and illustrates statistical methods appropriate for the analysis of environmental data obtained in biological or toxicological experiments. Beginning with basic probability and statistical inferences, this text progresses through non-linear and generalized linear models, trend testing, time-to-event data and analysis of cross-classified tabular and categorical data. For the more complex analyses, extensive examples including SAS and S-PLUS programming code are provided to assist the reader when implementing the methods in practice.

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

Toxicology is a comprehensive text for researchers and graduate students in toxicology and public health. It addresses every aspect of the field, starting with the fundamentals and incorporating such areas as organ toxicology, applications, and environmental toxicology. In addition to covering the traditional subject matter of toxicology, special emphasis has been placed on recent areas of interest, such as risk assessment, apoptosis, and methodical developments.Key Features* Comprehensive text, covering all aspects of the field of toxicology* Analyzes the importance of toxicokinetics and metabolism as well as cellular targets for the mechanisms of toxic effects* Identifies the various classes of chemical compounds responsible for the toxic effects* Describes the approaches and methods used by various disciplines which investigate toxic effects and their prevention* Adapted from a very successful German text, this edition is completely revised and expanded * The text is well illustrated with diagrams, charts, and tables

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.

A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.