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About the Book: · Comprehensive content covering all aspects of clinical research. · Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc. · Milestones in the evolution of drug regulations in India · Drug regulatory framework in India and key ICH countries. · Evolution of drug pricing mechanisms and IPRs in India. · Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017. · Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019. · Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc. 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
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