Drug Safety Evaluation

1. the Drug Development Process and the Global Pharmaceutical Marketplace
2. regulation of human Pharmaceutical Safety: routes to human use and Market
3. Data Mining: Sources of Information for consideration in Study and Program Design and in Safety evaluation
4. Screens in Safety and hazard assessment
5. formulations, routes, and Dosage regimens
6. nonclinical Manifestations, Mechanisms, and end Points of Drug toxicity
7. Pilot toxicity testing in Drug Safety evaluation: MtD and Drf
8. repeat‐Dose toxicity Studies
9. Genotoxicity
10. QSar tools for Drug Safety
11. Immunotoxicology in Drug Development
12. nonrodent animal Studies
13. Developmental and reproductive toxicity testing
14. carcinogenicity Studies
15. histopathology in nonclinical Pharmaceutical Safety assessment
16. Irritation and Local tissue tolerance in Pharmaceutical Safety assessment
17. Pharmacokinetics and toxicokinetics in Drug Safety evaluation
18. Safety Pharmacology
19. Special concerns for the Preclinical evaluation of biotechnology Products
20. Safety assessment of Inhalant Drugs and Dermal route Drugs
21. Special case Products: Imaging agents
22. Special case Products: Drugs for treatment of cancer
23. Pediatric Product Safety assessment (2006 Guidance, Including Juvenile toxicology)
24. use of Imaging, Imaging agents, and radiopharmaceuticals in nonclinical toxicology
25. occupational toxicology in the Pharmaceutical Industry
26. Strategy and Phasing for nonclinical Drug Safety evaluation in the Discovery and Development of Pharmaceuticals
27. the application of In Vitro techniques in Drug Safety assessment
28. evaluation of human tolerance and Safety in clinical trials: Phase I and beyond
29. Postmarketing Safety evaluation: Monitoring, assessing, and reporting of adverse Drug responses (aDrs)
30. Statistics in Pharmaceutical Safety assessment
31. combination Products: Drugs and Devices
32. Qualification of Impurities, Degradants, residual Solvents, Metals, and Leachables in Pharmaceuticals
33. tissue, cell, and Gene therapy

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition