A comprehensive guide to toxicology in nonclinical drug development
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicolo...
Enregistré dans:
| Hovedforfatter: | |
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| Format: | Livre numérique |
| Sprog: | Anglais |
| Udgivet: |
London :
Academic Press
2024.
Paris : Cyberlibris |
| Fag: | |
| Online adgang: | Accès Université d'Orléans et IFPM |
| Kommentar: |
Couverture. https://static2.cyberlibris.com/books_upload/300pix/9780323984621.jpg Cyberlibris (ScholarVox) corpus Santé |
| Autres localisations: | Voir dans le Sudoc |
| Edition sous un autre format: | • A comprehensive guide to toxicology in nonclinical drug development, edited by Ali S. Faqi,..., 3rd edition, 2024, London, Academic Press, 1 vol. (XVII-1053 p.), 978-0-323-85704-8 |
Indholdsfortegnelse:
- Section I. Drug Discovery, Metabolism, and Toxicokinetic
- Section II. Toxicological Studies and IND Application and First-In-Human Clinical Trial and Abuse Liability
- Section III. Clinical Pathology, Toxicological Pathology, Molecular Biology, and Biomarkers
- Section IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors
- Section V. Specialty Route of Administration
- Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines
- Section VII. Nonclinical Development of Oncogenic and Nononcogenic Drugs and Oligonucleotidebased Therapies and Vaccines
- Section VIII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices
- Section IX. Predictive Toxicology and Imaging
- 1. Introduction to Drug Development
- 2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls
- 3. Overview of ADME Science
- 4. Pharmacokinetics and Toxicokinetics in Drug Development
- 5. Development of Preclinical Formulations for Toxicology Studies
- 6. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development
- 7. Genetic Toxicology Testing
- 8. The Preparation of a Preclinical Dossier to Support an Investigational New Drug Application and First-In-Human Clinical Trial
- 9. Developmental and Reproductive Toxicology
- 10. Immunotoxicology Assessment in Drug Development
- 11. Juvenile Testing to Support Clinical Trials in Pediatric Population
- 12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models
- 13. Current Strategies for Abuse Liability Assessment of New Chemical Entities
- 14. Clinical Pathology in Nonclinical Toxicity Studies
- 15. Best Practice in Toxicologic Pathology
- 16. Molecular Pathology: Applications in Nonclinical Drug Development
- 17. Biomarkers in Nonclinical Drug Development
- 18. Biostatistics for Toxicologists
- 19. Regulatory Toxicologyc20. Study Directors and Study Monitors in Drug Development Safety Studies
- 21. Infusion Toxicology and Techniques
- 22. Photosafety AssessmentbIntroduction
- 23. Preclinical Development of Monoclonal Antibodies
- 24. Preclinical Development of Antibody-Drug Conjugates
- 25. Nonclinical Safety Assessment of Cell and Gene Therapies
- 26. How Gene Editing Is Changing Drug Development
- 27. Nonclinical Development of Oncology Drugs
- 28. Preclinical Development of Nononcogenic Drugs (Small and Large Molecules)
- 29. Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics
- 30. Animal Models for Infectious Disease Vaccine Development
- 31. Preclinical Toxicology of Vaccines
- 32. Safety Evaluation of Ocular Drugs
- 33. Nonclinical Safety Assessment of Botanical Products
- 34. Biocompatibility Evaluation of Medical Devices
- 35. Application of Evolving New Approach Methodologies for Chemical Safety Assessment
- 36. Use of Imaging for Preclinical Evaluation