Toxicologic Pathology: Nonclinical Safety Assessment (2nd Edition)

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

1. Preface
2. Acknowledgments
3. Editors
4. Contributors
5. Section I Concepts in Drug Development
   1. Chapter 1 Overview of Drug Development
      1. James A. Popp and Jeffery A. Engelhardt
   2. Chapter 2 Nonclinical Safety Evaluation of Drugs
      1. Thomas M. Monticello and Jeanine L. Bussiere
   3. Chapter 3 Nonclinical Safety Evaluation of Advanced Therapies
      1. Timothy K. MacLachlan, Kendall S. Frazier, and Mercedes Serabian
   4. Chapter 4 Nonclinical Safety Evaluation of Medical Devices
      1. Kathleen A. Funk, Victoria A. Hampshire, and JoAnn C. L. Schuh
   5. Chapter 5 Pathology and the Pathologist in Pharmaceutical Research and Development
      1. Page R. Bouchard, Christopher J. Clarke, and Dominique Brees
   6. Chapter 6 Routine and Special Techniques in Toxicologic Pathology
      1. Daniel J. Patrick, Matthew L. Renninger, and Peter C. Mann
   7. Chapter 7 Principles of Clinical Pathology
      1. Niraj K. Tripathi and Jacqueline M. Tarrant
   8. Chapter 8 Toxicokinetics and Drug Disposition
      1. David D. Christ
   9. Chapter 9 Toxicogenomics in Toxicologic Pathology
      1. Arun R. Pandiri, David E. Malarkey, and Mark J. Hoenerhoff
   10. Chapter 10 Spontaneous Lesions in Control Animals Used in Toxicity Studies
       1. Robert C. Johnson, Robert H. Spaet, Gitte Jeppesen, Ursula Junker, and Robert Stull
6. Section II Organ Systems
   1. Chapter 11 Gastrointestinal Tract
      1. Judit E. Markovits, Graham R. Betton, Donald N. McMartin, and Theresa Boulineau
   2. Chapter 12 Liver, Gallbladder, and Exocrine Pancreas
      1. Russell C. Cattley, James A. Popp, and Steven L. Vonderfecht
   3. Chapter 13 Respiratory System
      1. Tom P. McKevitt and David J. Lewis
   4. Chapter 14 Urinary System
      1. Kendall S. Frazier and John Curtis Seely
   5. Chapter 15 Hematopoietic System
      1. Kristin Henson, Tanasa Osborne, and Gregory S. Travlos
   6. Chapter 16 The Lymphoid System
      1. Patrick J. Haley
   7. Chapter 17 Bone, Muscle, and Tooth
      1. John L. Vahle, Joel R. Leininger, Philip H. Long, D. Greg Hall, and Heinrich Ernst
   8. Chapter 18 The Cardiovascular System
      1. Calvert Louden, David Brott, Chidozie J. Amuzie, Bindu Bennet, and Ronnie Chamanza
   9. Chapter 19 Endocrine Glands
      1. Richard A. Peterson, Sundeep Chandra, and Mark J. Hoenerhoff
   10. Chapter 20 Reproductive System and Mammary Gland
       1. Justin D. Vidal, Charles E. Wood, Karyn Colman, Katharine M. Whitney, and Dianne M. Creasy
   11. Chapter 21 Skin
       1. Zbigniew W. Wojcinski, Lydia Andrews-Jones, Daher Ibrahim Aibo, Rie Kikkawa, and Robert Dunstan
   12. Chapter 22 Nervous System
       1. Mark T. Butt, Alys Bradley, and Robert Sills
   13. Chapter 23 Special Senses: Eye and Ear
       1. Kenneth A. Schafer, Oliver C. Turner, and Richard A. Altschuler
       2. Index

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

Editors Biography

Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page Bouchard