A comprehensive guide to toxicology in nonclinical drug development. ([2016])

• Record Type: Book
• Further Information: Note: Edited by Ali Said Faqi.
• Editors: Faqi, Ali S
• Contents: 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
• Edition: Second edition
• Publisher Details: London, United Kingdom : Academic Press is an imprint of Elsevier
• Publication Date: 2016
• Copyright Date: 2017
• Extent: 1 online resource
• Subjects: 615.7/04; Drugs -- Toxicology; Drug development; Electronic books
• Languages: English
• ISBNs: 9780128036211; 0128036214
• Related ISBNs: 9780128036204
• Notes: Note: Online resource; title from PDF title page (ScienceDirect, viewed November 22, 2016).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.