A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics and moreUpdated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology INDICE: 1. Introduction2. ADME in Drug Discovery3. Pharmacokinetics and Toxicokinetics4. Acute, Sub-Acute, Sub-Chronic and Chronic, Dermal and Inhalation Toxicology5. Contemporary Practices in Core Safety Pharmacology Assessments6. Genetic Toxicology Testing7. Clinical Pathology8. Best Practice in Toxicologic Pathology9. Molecular Pathology: Applications in Nonclinical Drug Development10. Infusion Toxicology and Techniques11. The Preparation of a Nonclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials12. Developmental and Reproductive Toxicology13. Immunotoxicology Assessment in Drug Development14. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population15. Photosafety: Current Methods and Future Direction16. Dermal Toxicology17. Inhalation Toxicology18. 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 Entities20. Nonclinical Development of Monoclonal Antibodies21. Nonclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)22. Nonclinical Development of Oncology Drugs23. Safety Evaluation of Ocular Drugs24. Nonclinical toxicology of Vaccines 25. Stem Cells In Nonclinical Toxicology26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics27. Nonclinical Safety Assessment of Botanical Drugs28. Regulatory Toxicology29. Biostatistics for Toxicologists30. Role of Study Director and Study Monitor in Drug Development31. Use of Imaging for Nonclinical Evaluation32. Biomarkers in Toxicology33. Predictive Toxicology: Biological Assay Platforms34. Toxicometabolomics: Technology and Applications35. Toxicogenomics in Nonclinical Development36. Nonclinical Testing of Medical Devices37. The Pitfalls of Drug Development
- ISBN: 978-0-12-803620-4
- Editorial: Academic Press
- Encuadernacion: Cartoné
- Páginas: 1104
- Fecha Publicación: 01/10/2016
- Nº Volúmenes: 1
- Idioma: Inglés