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