2nd Edition

Toxicologic Pathology Nonclinical Safety Assessment, Second Edition

    1244 Pages 185 Color & 6 B/W Illustrations
    by CRC Press

    1244 Pages 185 Color & 6 B/W Illustrations
    by CRC Press

    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.





    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



    On page 12

    "...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