Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition

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

Summary

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

Chapter 1 Overview of Drug Development

Chapter 2 Nonclinical Safety Evaluation of Drugs

Chapter 3 Nonclinical Safety Evaluation of Advanced Therapies

Chapter 4 Nonclinical Safety Evaluation of Medical Devices

Chapter 5 Pathology and the Pathologist in Pharmaceutical Research and Development

Chapter 6 Routine and Special Techniques in Toxicologic Pathology

Chapter 7 Principles of Clinical Pathology

Chapter 8 Toxicokinetics and Drug Disposition

Chapter 9 Toxicogenomics in Toxicologic Pathology

Chapter 10 Spontaneous Lesions in Control Animals Used in Toxicity Studies

Chapter 11 Gastrointestinal Tract

Chapter 12 Liver, Gallbladder, and Exocrine Pancreas

Chapter 13 Respiratory System

Chapter 14 Urinary System

Chapter 15 Hematopoietic System

Chapter 16 The Lymphoid System

Chapter 17 Bone, Muscle, and Tooth

Chapter 18 The Cardiovascular System

Chapter 19 Endocrine Glands

Chapter 20 Reproductive System and Mammary Gland

Chapter 21 Skin

Chapter 22 Nervous System

Chapter 23 Special Senses: Eye and Ear

Editor(s) Bio

On page 12