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 designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical 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
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
