The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. - Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more - Includes practical examples on techniques and methods to guide your daily practice - Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

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.

As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Saf

Despite many encouraging developments in the field of animal-free technologies, well-defined animal models are still needed to study fundamental properties of human diseases and to develop new prophylactic and therapeutic treatments against human diseases. Non-human primates (NHP) make up only a small, but important, part of the total number of animals used in biomedical and preclinical research. Due to their close phylogenetic relationship and the shared susceptibility to many human diseases, NHP can provide important research models to study these diseases and, as such, play a critical role in the advancement of various areas in the medical field. Studies in NHP have contributed to our understanding of various diseases and fundamental biological phenomena and they continue to be important in the development of new therapies, treatments, drugs and vaccines. Moreover, NHP models also contribute to our general knowledge of the processes that underlie non-disease and disease conditions. Important areas where NHP can provide important information include (emerging) infectious diseases, organ transplantation, neurological and aging-related disorders. Although not covered in this book due to time constraints, the need for, and benefits of, NHP models has been demonstrated most recently in the SARS-CoV-2 pandemic. The present book is the second of two volumes and covers important disease areas where NHP are used as model species. This volume includes different chapters on NHP models in infectious diseases, aging, neurodegenerative disorders, organ transplantation and cancer.

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Spontaneous Pathology of the Laboratory Non-human Primate serves as a "go to" resource for all pathologists working on primates in safety assessment studies. In addition, it helps diagnostic veterinary pathologists rule out spontaneous non-clinical disease pathologies when assigning cause of death to species in zoological collections. Primate species included are rhesus, cynomolgus macaques and marmosets. Multi-authored chapters are arranged by organ system, thus providing the necessary information for continued research.Pathologists often face a lack of suitable reference materials or historical data to determine if pathologic changes they are observing in monkeys are spontaneous or a consequence of other treatments or factors. - Contains color illustrations that depict the most common lesions to augment descriptions - Covers descriptions that are compliant with the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) guidelines set forth by the Society of Toxicologic Pathology (STP) - Provides pathologists with common terms that are compliant with the FDA's Standard for Exchange of Nonclinical Data (SEND) guidelines

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.