Toxicologic Pathology Nonclinical Safety Assessment, Second Edition

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.

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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