Isbn: 9789389354836 - clinical research: principles practices perspectives (1 risultati)

Soft cover. Condizione: New. Contents: Section A: Drug Development: Recent Advances. 1. Newer Paradigms in Drug Development. Section B: Drug Regulations: International Scenario. 2. International Drug Regulations. Section C: Drug Regulations: Indian Scenario. 3. Evolution of Drug Regulations in India. 4. Drug Regulatory Framework in India. 5. Drug Approval Process in India. Section D: Drug Regulations: Specialized Areas of Clinical Research. 6. Clinical Research on Biologics. 7. Clinical Research on Traditional Medicine. 8. Clinical Research on Medical Devices. 9. Clinical Research on Stem Cells. 10. Clinical Research in Special Populations. 11. Bioavailability and Bioequivalence Studies. Section E: Clinical Research: Ethical Considerations. 12. Evolution of Ethics in Research. 13. Ethical Principles and Issues in Research. 14. Ethics Committee. 15. Informed Consent. 16. Compensation Issues in Clinical Trials. Section F: Clinical Research: An Overview. 17. Types and Principles of Clinical Research. Section G: Clinical Trials: Methodological Aspects. 18. Good Clinical Practice. 19. Practical Considerations in Designing and Conducting Clinical Trials. 20. Designs used in Clinical Trials. 21. Randomization. 22. Blinding. 23. Bias. 24. Compliance in Clinical Trials. 25. Clinical Trial Monitoring. 26. Data and Safety Monitoring Boards. 27. Clinical Data Management. 28. Case Report Form. 29. Quality Management in Clinical Research. 30. Biomarkers. 31. Multicentric Clinical Trials. Section H: Clinical Drug Development: Premarketing Phases. 32. Phase Zero Clinical Trials. 33. Phase 1 Clinical Trials. 34. Phase 2 and 3 Clinical Trials. Section I: Clinical Drug Development: Postmarketing Phases. 35. Phase 4 Research. 36. Post Marketing Surveillance. 37. Pharmacovigilance. 38. Drug Utilization Research. 39. Pharmacoepidemiology. 40. Pharmacoeconomics. Section J: Clinical Research: Special Areas. 41. Oncology Clinical Trials. 42. Clinical Research on Vaccines. 43. Orphan Drug Research. 44. Surgical Clinical Trials. Section K: Annexures.…