2nd Edition

Toxicology of the Gastrointestinal Tract, Second Edition

Edited By Shayne C. Gad Copyright 2019
    476 Pages 18 B/W Illustrations
    by CRC Press

    The gastrointestinal tract is the most important of the three major routes of entry (and clearance) of xenobiotics and biologic entities into the bodies of mammals. As such, it is also the major route for administration of pharmaceuticals to humans. Gastrointestinal Toxicology, Second Edition describes the mechanism for entry and clearance of xenobiotics, as well as the barriers, immunologic and metabolic issues, and functions present in the GI tract.

    Appearing in this volume are also considerations of the microbiome and its actions and influence on the function of the GI tract and on the toxicity and pharmacodynamics of ingested substances (including nutrients, toxins, and therapeutics). These fifteen chapters written by experienced experts in the field address methods to evaluate GI function; specifics of GI function and toxicity assessment in canines and minipigs; classes of compounds with their toxicity; species differences; and the toxicity (and promise) of nanoparticles. Those needing to understand the structure, function, and methods of studying the GI tract will find this volume a singular source of reference.




    Chapter 1 Introduction: The Gastrointestinal (GI) Tract as a Barrier and as an Absorptive and Metabolic Organ

    Shayne C. Gad

    Chapter 2 Methods for the Analysis of Gastrointestinal Function

    Robin C. Guy

    Chapter 3 Safety Pharmacology and the GI Tract

    Henry I. Jacoby

    Chapter 4 Gastrointestinal Tract Development and Its Importance in Toxicology

    Alma M. Feldpausch, Joseph V. Rodricks, Rosalind A. Schoof and Brittany A. Weldon

    Chapter 5 Gastrointestinal Tract as a Major Route of Pharmaceutical Administration

    Robert W. Kapp, Jr.

    Chapter 6 Gastrointestinal Function and Toxicology in Canines

    Charles B. Spainhour

    Chapter 7 Gastrointestinal Function and Toxicology in Minipigs

    Maria R. Jones and Alain Stricker-Krongrad

    Chapter 8 Absorption of Macromolecules by Mammalian Intestinal Epithelium

    Shayne C. Gad

    Chapter 9 Peyer’s Patch Epithelium: An Imperfect Barrier and Effect of the Microbiome

    Gary R. Burleson and Florence G. Burleson

    Chapter 10 Alteration of Intestinal Function by Xenobiotic Exposure: Animal Models

    Shayne C. Gad

    Chapter 11 The Role of the Microbiome on Metabolism, Absorption, and Toxicity of Xenobiotics in the Gastrointestinal Tract

    Shayne C. Gad

    Chapter 12 Normal and Abnormal Intestinal Absorption by Humans

    David W. Hobson and Valerie L. Hobson Balldin

    Chapter 13 Classes of Compounds with GI Tract Toxicity

    Amy L. Mihalchik and Erica N. Rogers

    Chapter 14 Species Differences in GI Toxicity

    Shayne C. Gad

    Chapter 15 Nanoparticles in the Gastrointestinal Tract

    David W. Hobson and Valerie L. Hobson Balldin



    Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and Ph.D. in Pharmacology/Toxicology (Texas, 1977), DABT, is the principal of Gad Consulting Services, a twenty-seven-year-old consulting firm with nine employees and more than 500 clients (including 140 pharmaceutical companies in the US and 50 overseas in 29 countries). Prior to this, he served in director-level and above positions at Searle, Synergen and Beckton Dickinson. He has published 50 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 42 years of broad-based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment, and genotoxicology. He is a past president of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections. He has direct involvement in the preparation of INDs (118 successfully to date), NDA, PLA, ANDA, 501(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs, and served as the COO of two pharmaceutical companies while a consultant. He has consulted for FDA, EPA, and NIH, has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 29 years. Dr. Gad is also a retired Navy officer with more than 26 years in service.