Toxicologic Pathology : Nonclinical Safety Assessment, Second Edition book cover
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Toxicologic Pathology
Nonclinical Safety Assessment, Second Edition




ISBN 9781498745307
Published August 27, 2018 by CRC Press
1224 Pages 185 Color & 6 B/W Illustrations

 
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Book Description

Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk.

Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions.

The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Table of Contents

Preface

Acknowledgments

Editors

Contributors

Section I Concepts in Drug Development

Chapter 1 Overview of Drug Development

James A. Popp and Jeffery A. Engelhardt

Chapter 2 Nonclinical Safety Evaluation of Drugs

Thomas M. Monticello and Jeanine L. Bussiere

Chapter 3 Nonclinical Safety Evaluation of Advanced Therapies

Timothy K. MacLachlan, Kendall S. Frazier, and Mercedes Serabian

Chapter 4 Nonclinical Safety Evaluation of Medical Devices

Kathleen A. Funk, Victoria A. Hampshire, and JoAnn C. L. Schuh

Chapter 5 Pathology and the Pathologist in Pharmaceutical Research and Development

Page R. Bouchard, Christopher J. Clarke, and Dominique Brees

Chapter 6 Routine and Special Techniques in Toxicologic Pathology

Daniel J. Patrick, Matthew L. Renninger, and Peter C. Mann

Chapter 7 Principles of Clinical Pathology

Niraj K. Tripathi and Jacqueline M. Tarrant

Chapter 8 Toxicokinetics and Drug Disposition

David D. Christ

Chapter 9 Toxicogenomics in Toxicologic Pathology

Arun R. Pandiri, David E. Malarkey, and Mark J. Hoenerhoff

Chapter 10 Spontaneous Lesions in Control Animals Used in Toxicity Studies

Robert C. Johnson, Robert H. Spaet, Gitte Jeppesen, Ursula Junker, and Robert Stull

Section II Organ Systems

Chapter 11 Gastrointestinal Tract

Judit E. Markovits, Graham R. Betton, Donald N. McMartin, and Theresa Boulineau

Chapter 12 Liver, Gallbladder, and Exocrine Pancreas

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

Chapter 13 Respiratory System

Tom P. McKevitt and David J. Lewis

Chapter 14 Urinary System

Kendall S. Frazier and John Curtis Seely

Chapter 15 Hematopoietic System

Kristin Henson, Tanasa Osborne, and Gregory S. Travlos

Chapter 16 The Lymphoid System

Patrick J. Haley

Chapter 17 Bone, Muscle, and Tooth

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

Chapter 18 The Cardiovascular System

Calvert Louden, David Brott, Chidozie J. Amuzie, Bindu Bennet, and Ronnie Chamanza

Chapter 19 Endocrine Glands

Richard A. Peterson, Sundeep Chandra, and Mark J. Hoenerhoff

Chapter 20 Reproductive System and Mammary Gland

Justin D. Vidal, Charles E. Wood, Karyn Colman, Katharine M. Whitney, and Dianne M. Creasy

Chapter 21 Skin

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

Chapter 22 Nervous System

Mark T. Butt, Alys Bradley, and Robert Sills

Chapter 23 Special Senses: Eye and Ear

Kenneth A. Schafer, Oliver C. Turner, and Richard A. Altschuler

Index

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Editor(s)

Biography

On page 12

Reviews

"...the editors have achieved a truly remarkable feat in pulling together over 70 of the top toxicologic pathologists, the majority of whom are still practicing in their respective fields.

"This book has much to recommend it to both the experienced toxicologist and toxicologic pathologist and to beginners in the field of drug development. The accumulated knowledge of the contributing authors, much of which has never been published before, makes this a classic that should be in use for many years to come."

-John R. Foster, ToxPath Sciences Ltd, Congleton, Cheshire, UK
Toxicologic Pathology 2019, Vol. 47(7) 902

Full review available at: https://journals.sagepub.com/doi/pdf/10.1177/0192623319861939