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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