This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics range from General Toxicology, to Genetic Toxicology, Human Clinical Toxicology, Histopathology, Clinical Pathology, Metabolism and Toxicokinetics, Risk Assessment, and more. New to this edition: Completely rewritten chapters covering immunotoxicology, endocrine toxicology, and reproductive and developmental toxicology, providing a fresh perspective on these topics Addition of new chapters on Chemical Toxicology, Pharmaceutical Toxicology, Juvenile Toxicology, and Safety Pharmacology Updated information dealing with Inhalation Toxicology, Neurotoxicology, and Regulatory Toxicology, which has been consolidated into single chapters for each specialty A separate glossary with toxicological terms presented both alphabetically and by toxicological subspecialty For nearly 20 years, this handbook has remained the only reference book of its kind, designed to facilitate easy access to information related to the various toxicology specialties. This updated edition of a popular reference book reflects current practices and the state of the science of toxicology.

The content of this book is intended to provide the toxicologist in drug development in the pharmaceutical and biotechnology industries with a broad understanding of bone and its interactions with other organ systems in safety assessments. The book is divided into three parts. The first part describes our current understanding of bone biology and its primary regulatory pathways. Additional chapters address regulatory and study design considerations for incorporating bone end points in toxicology studies, with special consideration being given to juvenile toxicology studies. This is intended to address recent regulatory requirements to evaluate skeletal development for drugs in development for pediatric populations. The second part of the book describes the principal techniques and methods used in bone research; understanding how these end-points are derived is fundamental to their appropriate application. These first two parts of the book provide the background and the means to develop the concepts in part three which describes bone and its interaction with other organ systems. The unique series of chapters in part three, contributed to by key leaders in their respective fields and in bone research, provides a comprehensive collective work. Although constantly evolving, the crosstalk and interaction of the skeleton with several organ systems is now recognized and well documented, such as for the reproductive system, muscle and kidney, while our understanding of the interaction with other organ systems, such as the immune system and CNS, is in its infancy. Recent work highlights the key role of the skeleton in the regulation of energy metabolism and the impact this has on research in metabolic diseases such as obesity and diabetes. The hope is that this book will enlighten many and encourage more to explore the impact of new compounds on the skeleton in the development of effective and safe drugs.

**Selected for Doody's Core Titles® 2024 in Toxicology** Reproductive and Developmental Toxicology, Third Edition is a comprehensive and authoritative resource, providing the latest literature on this complex subject by focusing on three core components - parent, placenta and fetus - and the continuous changes that occur in each. Enriched with relevant references describing every aspect of reproductive toxicology, this revised and updated resource addresses the totality of the subject, discussing a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, and metals, among others. In addition, it is the only resource to include reproductive and developmental toxicity in domestic animals, fish and wildlife With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages. Completely revised and updated to include the most recent developments in the field, this book is an essential resource for advanced students and researchers in toxicology, as well as biologists, pharmacologists and teratologists from academia, industry and regulatory agencies. - Provides a complete, up-to-date, integrated source of information on the key risk stages during reproduction and development - 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 - Includes new chapters on developments in systems toxicology and predictive modeling of male developmental toxicity, adverse outcome pathways in reproductive and developmental toxicology, ovarian and endometrial toxicity, developmental neurotoxicity of air pollution, and more

Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.