• Introduction: The Gastrointestinal Tract as a Barrier and as Absorptive and Metabolic Organ - Shayne C. Gad
• Methods for the Analysis of Gastrointestinal Function - Robin C. Guy
• Safety Pharmacology and the GI Tract - Henry I. Jacoby
• Gastrointestinal Tract Development and Its Importance in Toxicology - Alma M. Feldpauscha, Joseph V. Rodricksb, Rosalind A. Schoofa, and Brittany A. Weldona
• Gastrointestinal Tract as Major Route of Pharmaceutical Administration - Robert W. Kapp, Jr.
• Gastrointestinal Function and Toxicology in Canines - Charles B. Spainhour
• Gastrointestinal Function and Toxicology in Minipigs - Maria R. Jones & Alain Stricker-Krongrad
• Absorption of Macromolecules by Mammalian Intestinal Epithelium - Shayne C. Gad
• Peyer’s Patch Epithelium: An Imperfect Barrier and Effect of the Microbiome - Gary Burleson and Florence G. Burleson
• Alteration of Intestinal Function by Xenobiotic Exposure: Animal Models - Shayne C. Gad
• The Role of the Microbiome on Metabolism, Absorption, and Toxicity of Xenobiotics in the Gastrointestinal Tract - Shayne C. Gad
• Normal and Abnormal Intestinal Absorption by Humans - David W. Hobson and Valerie L. Hobson Balldin
• Classes of Compounds with GI Tract Toxicity - Amy Mihalchik-Burhans and Erica N. Rogers
• Species Differences in G.I. Toxicity - Shayne C. Gad
• Nanoparticles in the Gastrointestinal Tract - David W. Hobson and Valerie L. Hobson Balldin
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.
• Nanoparticles as both potential unique risks and as a valuable approach to increased and higher specificity in delivery of therapeutics
• A primer on the largest, most diverse, and important microbiome in any mammal
• "Tricks of the trade" on modifying the oral administration of drugs
Shayne Gad Ph.D., DABT is the principal of Gad Consulting Services, a twenty-five-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. Over the course of his 40 years of broad-based experience in the fields of toxicology, drug and device development, statistics, and risk assessment, he has published 50 books and more than 350 chapters, articles, and abstracts. He has direct involvement in the preparation of INDs (118 successfully to date), NDA, PLA, ANDA, 501(k), IDE, CTD, clinical databases for phase 1 and 2 studies, and PMAs. He has consulted for the FDA, EPA, and NIH, has trained reviewers, and been an expert witness for the FDA. Dr. Gad is also a retired Navy officer with more than 26 years in service.