A Comprehensive Guide to Toxicology in Preclinical Drug Development

Edited by

  • Ali S. Faqi, DVM, PhD, DABT, ATS, Dr. Ali Faqi is the Senior Director Developmental & Reproductive Toxicology, MPI Research, Mattawan, MI USA

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.

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Audience

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.

 

Book information

  • Published: November 2012
  • Imprint: ACADEMIC PRESS
  • ISBN: 978-0-12-387815-1

Reviews

"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




Table of Contents

  1. Introduction
  2. ADME in Drug Discovery
  3. Pharmacokinetics and Toxicokinetics
  4. Development of Preclinical Formulations for Toxicology Studies
  5. Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development 
  6. Contemporary Practices in Core Safety Pharmacology Assessments
  7. Genetic Toxicology Testing
  8. Clinical Pathology
  9. Best Practice in Toxicologic Pathology
  10. Molecular Pathology: Applications in Nonclinical Drug Development
  11. Infusion Toxicology and Techniques
  12. The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials
  13. Developmental and Reproductive Toxicology
  14. Immunotoxicology Assessment in Drug Development
  15. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population
  16. Photosafety: Current Methods and Future Direction
  17. Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay
  18. Carcinogenicity Evaluations using Genetically Engineered Animals
  19. Current Strategies for Abuse Liability Assessment of New Chemical Entities
  20. Impact of Product Attributes on Preclinical Safety Evaluation
  21. Preclinical Development of Monoclonal Antibodies
  22. Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)
  23. Preclinical Development of Oncology Drugs
  24. Safety Evaluation of Ocular Drugs
  25. Preclinical toxicology of Vaccines
  26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics
  27. Nonclinical Safety Assessment of Botanical Drugs
  28. Regulatory Toxicology
  29. New Drug Regulation and Approval in China
  30. Biostatistics for Toxicologists
  31. Role of Study Director and Study Monitor in Drug Development
  32. Use of Imaging for Preclinical Evaluation
  33. Predictive Toxicology: Biological Assay Platforms
  34. Toxicometabolomics: Technology and Applications
  35. Toxicogenomics in Preclinical Development
  36. Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm