Histopathology of Preclinical Toxicity Studies: Interpretation and Relevance in Drug Safety Evaluation

by Peter Greaves

Overview

This work covers effectively all aspects of drug-induced pathology that may be encountered within preclinical toxicity studies. It fills a gap in the pathology literature relating to the preclinical safety assessment of new medicines. It systematically describes, in one volume, both spontaneous and drug induced pathology on an organ by organ basis. Information relevant to understanding the nature of pathological changes in pre-clinical studies and assessment of their relevance to the clinical investigation of new drugs is also covered. Numerous colour photographs are included that highlight and embellish the histopathological features that are described. It also contains many pertinent references to both human and animal pathology forming an essential basis for the assessment of drug-induced pathology.

NEW TO THE THIRD EDITION:
* Covers drug induced pathology in preclinical (animal) studies and their relevance for patients or volunteers in clinical studies
* General comments to each chapter about the relevance of pathological findings to humans
* Provides essential information that can help decide the relevance of particular lesions for patients

Product Details

ISBN-13:	9780080471303
Publisher:	Elsevier Science
Publication date:	03/23/2007
Sold by:	Barnes & Noble
Format:	eBook
Pages:	960
File size:	35 MB
Note:	This product may take a few minutes to download.

About the Author

MBChB, FRCPath, Consulting Pathologist and Honorary Senior Lecturer, Department of Cancer Studies and Molecular Medicine, University of Leicester, UK

Table of Contents

Introduction
Integumentary System
Mammary Gland
Haemopoietic and Lymphatic Systems
Musculoskeletal System
Respiratory Tract
Cardiovascular System
Gastrointestinal tract

What People are Saying About This

From the Publisher

Filling an important gap in the pathology literature related to the preclinical safety assessment of new drugs, this book describes the pathology found in drug safety studies in laboratory animals and the relevance of these pathological findings to humans

Editorial Reviews

Reviewer: Hartmut Jaeschke, PhD (University of Kansas Medical Center)
Description: This is a comprehensive overview of drug-induced histopathological changes in all organs or organ systems of experimental animals. To facilitate the extrapolation of animal data to humans, the author compares and discusses the adverse effects observed in animals with those in humans. The previous editions were published in 1991 and 2000.
Purpose: The purpose is to provide a comprehensive resource that can assist in the identification of adverse reactions in experimental animals, facilitate the extrapolation to humans, and assist in risk assessment. The book successfully addresses a critical need and one of the most challenging problems in drug development.
Audience: Professionals who are involved in preclinical drug safety studies, the interpretation of the results of safety studies, and the extrapolation to humans are the main audience. Therefore, this book is invaluable for veterinary pathologists, study directors, toxicology consultants, and other drug safety scientists/managers in the pharmaceutical industry. In addition, it is an excellent resource for scientists who are involved in studies of mechanistic or investigative toxicology in industry or academia. The author is a professional pathologist with an extensive publication record in this field.
Features: The book is organized into chapters that cover major organs and organ systems. In each chapter, the author gives an overview of the human drug-induced pathology followed by extensive discussion of preclinical studies. He then describes morphological and functional aspects of the healthy organ system and details the pathological changes induced by various drugs. The author does not just describe facts, he also provides valuable insight into the interpretation of preclinical studies and consistently relates the preclinical findings to the human pathophysiology. The numerous examples of drug-induced pathologies listed in the book are supported by many high quality color illustrations. At the end of each chapter, the author provides a representative reference list, which includes up-to-date citations as well as critical older references. This gives readers a valuable starting point into the primary literature.
Assessment: This is a high quality book that provides essential information needed by every professional involved in the execution and interpretation of preclinical drug safety studies and their extrapolation to humans. Beyond that, the book is also highly useful for academic investigators dealing with adverse drug effects in vivo. The latest edition maintains the general format of previous editions, but provides critical updates of new developments during the last 10 years.

Doody's Review Service

"The present second edition of this comprehensive and ambitious compendium is an updated version of the first issue published in 1990. ...I recommend the book for those who are directly involved in standard preclinical studies on effects of drugs and related chemicals." —Archive of Fishery and Marine Research

"This work is a veritable 'tour-de-force' of which the author can be justifiably proud. It is the second edition of the book, first published about twelve years ago, and this version, like the previous, is exemplary. If this is your field then this is your book. Excellent." —ISSX Newsletter

From the Publisher