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