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. Chapters written by world-renowned contributors who are experts in their fieldsIncludes the latest research in preclinical drug testing and international guidelinesCovers preclinical toxicology in small molecules and biologics in one single source INDICE: 1. Introduction2. Discovery ADME3. Pharmacokinetics/Toxicokinetics4. Development of Preclinical Formulations for Toxicology Studies5. Acute, sub-acute and chronic toxicity testing 6. Safety Pharmacology7. Genetic Toxicology8. Clinical Pathology9. Best Practice in Toxicologic Pathology10. Molecular pathology in preclinical Toxicology11. Infusion Toxicology12. The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials13. Developmental & Reproductive Toxicology14. Immunotoxicology15. Toxicity Studies to Support Clinical Trials in Pediatric Population 16. Photoxicity17. 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 Drugs25. 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 Toxicology29. Chinese Drug Regulations 30. Biostatistics for Toxicologists 31. Study Director and Preclinical Study Monitoring Role 32. Use of Imaging for Preclinical Evaluation33. Predictive Toxicology34. Metabolics in Toxicology35. Toxicogenomics in Drug Development36. Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm to Toxicology in Preclinical Drug Development
- ISBN: 978-0-12-387815-1
- Editorial: Academic Press
- Encuadernacion: Cartoné
- Páginas: 1024
- Fecha Publicación: 10/12/2012
- Nº Volúmenes: 1
- Idioma: Inglés