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
Description
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.
Readership
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.
A Comprehensive Guide to Toxicology in Preclinical Drug Development, 1st Edition
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
