Description
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
Table of Contents
Section I- Overview of Pharmaceutical Medicine 1. The Specialty of Pharmaceutical MedicineSection II- Drug Discovery and Development 2. Drug Discovery and Development: An overview3. Pharmaceutical Development4. Preclinical Drug Development5. Target Product Profile and Clinical Development Plan6. Clinical Pharmacokinetics and Drug Interactions7. Pharmacogenomics: An Evolution Towards Clinical Practice8. Clinical Research Quality Assurance and AuditsSection III- Pharmaceutical Law and Ethics 9. Pharmaceutical Medicine and Law10. Pharmaceutical Regulations in the United States11. Pharmaceutical Regulations in European Union12. Pharmaceutical Regulations in India13. Pharmaceutical Regulations for Complementary Medicine14. Ethical Considerations in Clinical ResearchSection IV- Pharmaceutical Industry and Intellectual Property Rights 15. Patent16. Copyright17. Trademark18. Trade Secret19. Data ExclusivitySection V- Generics, Supergenerics, Biologics, biosimilars and bio-betters 20. Generic Drug and Bioequivalence Studies21. Vaccines22. Biosimilars23. Re-innovation in Pharmaceutical Industry: Supergenerics and BiobettersSection VI- Medical Services 24. Phase IV Studies and Lifecycle Management25. Medical AffairsSection VII- Pharmacovigilance 26. Pharmacovigilance and Drug Safety27. Clinical and Post Approval Safety Data Management28. Individual Case Safety Reports29. Development and Periodic Safety Reports30. Risk Management in Pharmacovigilance31. Recent Developments in Pharmacovigilance at UMCSection VIII- Drug utilization and Pharmacoeconomics 32. Assessing Medicine Use and Tools for Monitoring Medicine Use33. Pharmacoeconomics and Healthcare
-
- 洋書
- LUXE EXTREME
-
- 洋書電子書籍
-
アメリカ都市の形態学
The S…
