the nonhuman primate in nonclinical drug development and safety assessment

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Annotation This reference compiles 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, it

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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,

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Challenges in Nonhuman Primate Research in the 21st Century

In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd & 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium. The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the

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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples

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Drug Discovery Toxicology

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

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Principles of Safety Pharmacology

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current

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Drug Safety Evaluation

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including

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Model Organisms for Microbial Pathogenesis  Biofilm Formation and Antimicrobial Drug Discovery

This book provides essential insights into microbial pathogenesis, host-pathogen interactions, and the anti-microbial drug resistance of various human pathogens on the basis of various model organisms. The initial sections of the book introduce readers to the mechanisms of microbial pathogenesis, host-pathogen interactions, anti-microbial drug resistance, and the dynamics of biofilm

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The Laboratory Nonhuman Primate

Extensively updated to include current literature, The Laboratory Nonhuman Primate, Second Edition, continues to serve as a quick reference source for technicians, caretakers, veterinarians, researchers, and students working with primates in biomedical research. It provides details on basic husbandry and covers biologic characteristics, regulatory compliance, common diseases, and anesthetic management.

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Drug Safety Evaluation

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including

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Toxicologic Pathology for Non Pathologists

This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help

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Essentials of Laboratory Animal Science  Principles and Practices

This book comprehensively reviews the anatomy, physiology, genetics and pathology of laboratory animals as well as the principles and practices of using laboratory animals for biomedical research.It covers the design of buildings used for laboratory animals, quality control of laboratory animals, and toxicology, and discusses various animal models used

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Infant Formula

Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines

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Histopathology of Preclinical Toxicity Studies

Histopathological assessment of tissue sections is an important componant of many preclinical studies which are conducted to support the safety and clinical development of novel therapeutic agents for use in the treatment of human diseases. The drug discovery process, aided by modern biotechnology, is now capable of generating highly potent,

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Toxicology of the Gastrointestinal Tract  Second Edition

The gastrointestinal tract is the most important of the three major routes of entry (and clearance) of xenobiotics and biologic entities into the bodies of mammals. As such, it is also the major route for administration of pharmaceuticals to humans. Gastrointestinal Toxicology, Second Edition describes the mechanism for entry and

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