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

Graduate and postgraduate students in the areas of clinical research, pharmaceutical medicine, clinical pharmacology and pharmacy, as well as professors teaching in these areas; also professionals working in the pharmaceutical industry or contract research organizations and drug regulatory authorities

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