Cargando…
A comprehensive guide to toxicology in nonclinical drug development /
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, United Kingdom :
Academic Press is an imprint of Elsevier,
[2016]
|
| Edición: | Second edition. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 1. Introduction; 2. ADME in Drug Discovery; 3. Pharmacokinetics and Toxicokinetics; 4. Acute, Sub-Acute, Sub-Chronic and Chronic, Dermal and Inhalation Toxicology; 5. Contemporary Practices in Core Safety Pharmacology Assessments; 6. Genetic Toxicology Testing; 7. Clinical Pathology; 8. Best Practice in Toxicologic Pathology; 9. Molecular Pathology: Applications in Nonclinical Drug Development; 10. Infusion Toxicology and Techniques; 11. The Preparation of a Nonclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials; 12. Developmental and Reproductive Toxicology; 13. Immunotoxicology Assessment in Drug Development; 14. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population; 15. Photosafety: Current Methods and Future Direction; 16. Dermal Toxicology; 17. Inhalation Toxicology; 18.
- Nonclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay and Carcinogenicity Evaluations using Genetically Engineered Animals; 19 Current Strategies for Abuse Liability Assessment of New Chemical Entities; 20. Nonclinical Development of Monoclonal Antibodies; 21. Nonclinical Development of Non-Oncogenic Drugs (Small and Large Molecules); 22. Nonclinical Development of Oncology Drugs; 23. Safety Evaluation of Ocular Drugs; 24. Nonclinical toxicology of Vaccines; 25. Stem Cells In Nonclinical Toxicology; 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. Biostatistics for Toxicologists; 30. Role of Study Director and Study Monitor in Drug Development; 31. Use of Imaging for Nonclinical Evaluation; 32. Biomarkers in Toxicology; 33. Predictive Toxicology: Biological Assay Platforms; 34.
- Toxicometabolomics: Technology and Applications; 35. Toxicogenomics in Nonclinical Development; 36. Nonclinical Testing of Medical Devices; 37. The Pitfalls of Drug Development