A Comprehensive Guide to Toxicology in Preclinical Drug Development book cover

A Comprehensive Guide to Toxicology in Preclinical Drug Development

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.

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.

Hardbound, 1024 Pages

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


Contents

  • 1. Introduction
    2. Discovery ADME
    3. Pharmacokinetics/Toxicokinetics
    4. Development of Preclinical Formulations for Toxicology Studies
    5. Acute, sub-acute and chronic toxicity testing
    6. Safety Pharmacology
    7. Genetic Toxicology
    8. Clinical Pathology
    9. Best Practice in Toxicologic Pathology
    10. Molecular pathology in preclinical Toxicology
    11. Infusion Toxicology
    12. The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials
    13. Developmental & Reproductive Toxicology
    14. Immunotoxicology
    15. Toxicity Studies to Support Clinical Trials in Pediatric Population
    16. Photoxicity
    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. Preclinical Development of Botanical Drugs
    28. Regulatory Toxicology
    29. Chinese Drug Regulations
    30. Biostatistics for Toxicologists
    31. Study Director and Preclinical Study Monitoring Role  
    32. Use of Imaging for Preclinical Evaluation
    33. Predictive Toxicology
    34. Metabolics in Toxicology
    35. Toxicogenomics in Drug Development
    36. Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm to Toxicology in Preclinical Drug Development

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