Toxicologic Pathology, Nonclinical Safety Assessment, 2nd Edition

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Toxicologic Pathology, Nonclinical Safety Assessment, 2nd Edition

Toxicologic Pathology, Nonclinical Safety Assessment 2Nd Edition Pdf

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

Toxicologic Pathology, Nonclinical Safety Assessment, 2nd Edition PDF 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.

Read more: Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

Table of Contents

Preface

Acknowledgments

Editors

Contributors

Section Iโ€ƒConcepts in Drug Development

Chapter 1ย Overview of Drug Development

James A. Popp and Jeffery A. Engelhardt

Chapter 2ย Nonclinical Safety Evaluation of Drugs

Thomas M. Monticello and Jeanine L. Bussiere

Chapter 3ย Nonclinical Safety Evaluation of Advanced Therapies

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

Chapter 4ย Nonclinical Safety Evaluation of Medical Devices

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

Chapter 5ย Pathology and the Pathologist in Pharmaceutical Research and Development

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

Chapter 6ย Routine and Special Techniques in Toxicologic Pathology

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

Chapter 7ย Principles of Clinical Pathology

Niraj K. Tripathi and Jacqueline M. Tarrant

Chapter 8ย Toxicokinetics and Drug Disposition

David D. Christ

Chapter 9ย Toxicogenomics in Toxicologic Pathology

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

Chapter 10ย Spontaneous Lesions in Control Animals Used in Toxicity Studies

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

Section IIโ€ƒOrgan Systems

Chapter 11ย Gastrointestinal Tract

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

Chapter 12ย Liver, Gallbladder, and Exocrine Pancreas

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

Chapter 13ย Respiratory System

Tom P. McKevitt and David J. Lewis

Chapter 14ย Urinary System

Kendall S. Frazier and John Curtis Seely

Chapter 15ย Hematopoietic System

Kristin Henson, Tanasa Osborne, and Gregory S. Travlos

Chapter 16ย The Lymphoid System

Patrick J. Haley

Chapter 17ย Bone, Muscle, and Tooth

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

Chapter 18ย The Cardiovascular System

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

Chapter 19ย Endocrine Glands

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

Chapter 20ย Reproductive System and Mammary Gland

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

Chapter 21ย Skin

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

Chapter 22ย Nervous System

Mark T. Butt, Alys Bradley, and Robert Sills

Chapter 23ย Special Senses: Eye and Ear

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

Index

File Size 350MB
File Format Pdf
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