Toxicologic Pathology: Nonclinical Safety Assessment, 1st Edition (Paperback) book cover

Toxicologic Pathology

Nonclinical Safety Assessment, 1st Edition

Edited by Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath

CRC Press

1,015 pages | 140 Color Illus. | 18 B/W Illus.

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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 Safety Assessment presents a histopathologic description of lesions observed during drug development and discusses their implication in the drug development process.

Divided into two sections, the book systematically assists pathologists in making a determination as to the origin and potential importance of a lesion and its relevance for assessing human risk. The first section includes eight "concept" chapters to orient pathologists in areas that are important for effective interaction with other pathologists as well as the many non-pathologists involved in drug development. The second section is made up of organ-based chapters, each including light microscopic and electron microscopic descriptions of pathological lesions, differential diagnoses, biological consequences, pathogenesis, mechanism of lesion formation, and the expected clinical pathology correlates.

This volumepresents critical information—both published and unpublished and gained through personal experience—to improve the quality of drug safety evaluation and to expedite and improve the efficiency of the process. This book is crafted to assist students, residents, and toxicologic pathologists in their early career phase by serving as a resource that can effectively be used as a ready reference next to the microscope. In addition, more experienced pathologists will find this volume to be invaluable during their assessments. The book is also a valuable reference for toxicologists to assist in understanding compound-related pathological findings and to provide background for working on a range of toxicological problems.


" … the most practical textbook directly available for toxicological research that has been published in recent years … will be a highly valuable aid for toxicologic pathologists working in pharmaceutical drug research at all stages of their training or career."

Journal of Toxicologic Pathology

"Overall, this is a detailed and up-to-date textbook, appropriate for toxicologic pathologists at different stages of their career who require a quick, but informative, reference. The authors are globally recognised, so each chapter in the book is well structured with extensive reference lists."

—Catherine L. Ross, Covance Laboratories Ltd, UK in bst News

"In summary, this book will serve as an outstanding contemporary resource for practicing and research toxicologists, whether in an industry or academic setting. It is expansive in its coverage and a pleasure to read."

—Mary Beth Genter, PhD, DABT, in International Journal of Toxicology

"I highly recommend this book for pathologists and nonpathologists working in the field of safety assessment and the many other uses of animals in medical research. A real expert reference book."

—Jerrold M. Ward, DVM, PhD, DACVP, in Veterinary Pathology Online

Table of Contents

Concepts in Drug Development

Overview of Drug Development

James A. Popp and Jeffery A. Engelhardt

Nonclinical Safety Evaluation of Drugs

Thomas M. Monticello and Jeanine L. Bussiere

Toxicokinetics and Drug Disposition

David D. Christ

Introduction to Toxicologic Pathology

Judit E. Markovits, Page R. Bouchard, Christopher J. Clarke, and Donald N. McMartin

Routine and Special Techniques in Toxicologic Pathology

Daniel J. Patrick and Peter C. Mann

Principles of Clinical Pathology

Robert L. Hall

Toxicogenomics in Toxicologic Pathology

Mark J. Hoenerhoff and David E. Malarkey

Spontaneous Lesions in Control Animals Used in Toxicity Studies

Robert C. Johnson, Robert H. Spaet, and Daniel L. Potenta

Organ Systems

Gastrointestinal Tract

Judit E. Markovits, Graham R. Betton, Donald N. McMartin, and Oliver C. Turner

Liver, Gallbladder, and Exocrine Pancreas

Russell C. Cattley, James A. Popp, and Steven L. Vonderfecht

Respiratory System

David J. Lewis and Tom P. McKevitt

Urinary System

Kendall S. Frazier and John Curtis Seely

Hematopoietic System

Kristin Henson, Glenn Elliott, and Gregory S. Travlos

Lymphoid System

Patrick J. Haley

Bone, Muscle, and Tooth

John L. Vahle, Joel R. Leininger, Philip H. Long, D. Greg Hall, and Heinrich Ernst

Cardiovascular System

Calvert Louden and David Brott

Endocrine Glands

Sundeep Chandra, Mark J. Hoenerhoff, and Richard Peterson

Reproductive System and Mammary Gland

Justin D. Vidal, Michael L. Mirsky, Karyn Colman, Katharine M. Whitney, and Dianne M. Creasy


Zbigniew W. Wojcinski, Lydia Andrews-Jones, Daher Ibrahim Aibo, and Robert Dunstan

Nervous System

Mark T. Butt, Robert Sills, and Alys Bradley

Special Senses: Eye and Ear

James A. Render, Kenneth A. Schafer, and Richard A. Altschuler

About the Editors

Pritam S. Sahota is the Executive Director of Special Projects Pathology at the Novartis Institutes for Biomedical Research in East Hanover, New Jersey, USA.

James A. Popp is with Stratoxon LLC in Lancaster, Pennsylvania, USA. Jerry F. Hardisty is with Experimental Pathology Laboratories in Sterling, Virginia.

Chirukandath Gopinath is an Independent Consultant in Toxicology/Pathology in Cambridgeshire, UK.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pathology
MEDICAL / Pharmacology
MEDICAL / Toxicology