Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.

As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.

Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Section I- Overview of Pharmaceutical Medicine 1. The Specialty of Pharmaceutical Medicine

Section II- Drug Discovery and Development 2. Drug Discovery and Development: An overview 3. Pharmaceutical Development 4. Preclinical Drug Development 5. Target Product Profile and Clinical Development Plan 6. Clinical Pharmacokinetics and Drug Interactions 7. Pharmacogenomics: An Evolution Towards Clinical Practice 8. Clinical Research Quality Assurance and Audits

Section III- Pharmaceutical Law and Ethics 9. Pharmaceutical Medicine and Law 10. Pharmaceutical Regulations in the United States 11. Pharmaceutical Regulations in European Union 12. Pharmaceutical Regulations in India 13. Pharmaceutical Regulations for Complementary Medicine 14. Ethical Considerations in Clinical Research

Section IV- Pharmaceutical Industry and Intellectual Property Rights 15. Patent 16. Copyright 17. Trademark 18. Trade Secret 19. Data Exclusivity

Section V- Generics, Supergenerics, Biologics, biosimilars and bio-betters 20. Generic Drug and Bioequivalence Studies 21. Vaccines 22. Biosimilars 23. Re-innovation in Pharmaceutical Industry: Supergenerics and Biobetters

Section VI- Medical Services 24. Phase IV Studies and Lifecycle Management 25. Medical Affairs

Section VII- Pharmacovigilance 26. Pharmacovigilance and Drug Safety 27. Clinical and Post Approval Safety Data Management 28. Individual Case Safety Reports 29. Development and Periodic Safety Reports 30. Risk Management in Pharmacovigilance 31. Recent Developments in Pharmacovigilance at UMC

Section VIII- Drug utilization and Pharmacoeconomics 32. Assessing Medicine Use and Tools for Monitoring  Medicine Use 33. Pharmacoeconomics and Healthcare