Bikash Medhi eBooks
eBooks di Bikash Medhi editi da Pharmamed Press
Clinical ResearchPrinciples, Practice and Perspective. E-book. Formato EPUB Bikash Medhi - Pharmamed Press, 2021 -
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 Advances1. Newer Paradigms in Drug DevelopmentSection – B - Drug Regulations: International Scenario2. International Drug RegulationsSection – C - Drug Regulations: Indian Scenario3. Evolution of Drug Regulations in India4. Drug Regulatory Framework in India5. Drug Approval Process in IndiaSection – D - Drug Regulations: Specialized Areas of Clinical Research6. Clinical Research on Biologics7. Clinical Research on Traditional Medicine8. Clinical Research on Medical Devices9. Clinical Research on Stem Cells10. Clinical Research in Special Populations11. Bioavailability and Bioequivalence StudiesSection – E - Clinical Research: Ethical Considerations12. Evolution of Ethics in Research13. Ethical Principles and Issues in Research14. Ethics Committee15. Informed Consent16. Compensation Issues in Clinical TrialsSection – F - Clinical Research: An Overview17. Types and Principles of Clinical ResearchSection – G - Clinical Trials: Methodological Aspects18. Good Clinical Practice19. Practical Considerations in Designing and Conducting Clinical Trials20. Designs used in Clinical Trials21. Randomization22. Blinding23. Bias24. Compliance in Clinical Trials25. Clinical Trial Monitoring26. Data and Safety Monitoring Boards27. Clinical Data Management28. Case Report Form29. Quality Management in Clinical Research30. Biomarkers31. Multicentric Clinical TrialsSection – H - Clinical Drug Development: Premarketing Phases32. Phase Zero Clinical Trials