A Comprehensive Guide to Toxicology in Preclinical Drug Development

1st Edition

Editors: Ali S. Faqi
Hardcover ISBN: 9780123878151
eBook ISBN: 9780123878168
Imprint: Academic Press
Published Date: 2nd November 2012
Page Count: 1024
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Institutional Access


A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications.

By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing.

Key Features

  • Chapters written by world-renowned contributors who are experts in their fields
  • Includes the latest research in preclinical drug testing and international guidelines
  • Covers preclinical toxicology in small molecules and biologics in one single source


The primary audience includes practicing toxicologists and recent graduates in toxicology who are working in or thinking about working in the pharmaceutical industry. This book will also be valuable for study directors working in contract research organizations (CRO) and toxicologists working for regulatory agencies across the world.

Table of Contents




Chapter 1. Introduction

Chapter 2. ADME in Drug Discovery



Use of Preclinical ADME Data

Two Evolving Technologies Impacting ADME in Drug Discovery


Chapter 3. Pharmacokinetics and Toxicokinetics


Drug Administration and Delivery

Intravenous Administration

Absorption after Extravascular Dosing

Calculation of Exposure-Based Safety Margins

Practical Considerations



Chapter 4. Development of Preclinical Formulations for Toxicology Studies


Animal Species, Sampling Volumes and Sampling Sites

Dosing Route

Dosing Volume

Formulation Development

Physico-Chemical Property Characterization

Solubility Enhancement

Special Dosage Forms

Decision Tree

In Vitro Evaluation of the Performance of a Toxicological Study

Case Study

Concluding Remarks


Chapter 5. Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development


Regulatory Considerations for Conducting Preclinical Toxicology Studies

General Considerations for the Conduct of Preclinical Toxicology Studies

Study Types Used in the Assessment of General Toxicology

Special Considerations for Biopharmaceutical Safety Evaluations

Common Protocol Components of General Toxicity Assessments in GLP Studies

Final Thoughts


Chapter 6. Contemporary Practices in Core Safety Pharmacology Assessments

Background and Overview

Safety Pharmacology as a Regulatory Science

Temporal Application of Current Experimental Paradigms

Cardiovascular System and Models of Safety Assessment

Cardiac Ion Channels and


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© Academic Press 2013
Academic Press
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About the Editor

Ali S. Faqi

Ali Said Faqi, DVM, PhD, DABT, ATS, is a Senior Director of Developmental and Reproductive Toxicology, a Senior Principal Scientist at MPI Research and an Adjunct Associate Professor at Wayne State University, School of Medicine, Department of OBGYN in Detroit, MI. He received his Ph.D. from the University of Leipzig in Germany in 1995 and D.V.M. from Somali National University. Dr. Faqi earned a diploma of specialization in Experimental Pharmacology from the University of Milan in Italy. He was a postdoctoral fellow at the Institute of Clinical Pharmacology and Toxicology at the Free University of Berlin-Germany from 1996 till 1998. He worked as a Research Associate at Morehouse School of Medicine in Atlanta, Georgia and at Thomas Jefferson University in Philadelphia, Pennsylvania. Before joining MPI Research, Dr. Faqi was a Senior Scientist at Allergan Pharmaceuticals in Irvine, California and a Research Toxicologist at IIT Research Institute in Chicago, Illinois. He is a Diplomate of American Board of Toxicology (D.A.B.T.) and a Fellow of Academy of Toxicological Sciences (A.T.S.). Dr. Faqi is a member of the Editorial Board of Reproductive Toxicology Journal and ISRN Toxicology. He served as a Board of Scientific Counselors (BOSC) Computational Toxicology at the United States Environmental Protection Agency (US EPA) from September, 2009-September, 2010. He is also a member of Scientific Advisory Board of the Alzheimer's Art Quilt Initiative (AAQI). Dr. Ali Faqi is ad-hoc scientific reviewer for the scientific journals (Regulatory Pharmacology and Toxicology, Toxicology Journal, System Biology in Reproductive Medicine, Pesticide Biochemistry and Physiology, PLoS ONE and Birth Defects Research Part B: Developmental & Reproductive Toxicology). He is a Visiting Professor at the University of Palermo, Italy. In 2009, Dr. Faqi was a guest speaker at King Fahd Medical Research Center in King Abdiaziz University, Jeddah (Saudi Arabia) where he lectured on Precli

Affiliations and Expertise

Senior Director of Developmental and Reproductive Toxicology, MPI Research, Mattawan, MI, USA


"…a wide-ranging overview of various areas of toxicology, covering a relatively novel selection of subject areas that are not normally seen together...This book is reasonably priced…it would be a good addition to a toxicologist’s bookshelf or an Institution’s library."--BTS Newsletter, Summer 2013
"This book will be an important addition to the libraries of researchers in toxicology and related disciplines, and with its comprehensive approach to preclinical toxicology, it will be a key reference for any medical professional interested in drug development."--Journal of the American Veterinary Medicine Association, December 15, 2013
"The first new toxicology text to address both small and large molecules within the drug development process with contributions from leading scientists from around the globe is now available. Published by Elsevier, A Comprehensive Guide to Toxicology in Preclinical Drug Development covers the entire process of preclinical drug testing, beginning with investigative toxicology and includes the evaluation of the toxicologic and pharmacologic effects of new chemical entities, as well as in vitro and in vivo laboratory animal testing."--Drug Discovery Online, March 29, 2013
"Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology…By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing."--VeterinaryWorld.org, April 17, 2013