
Pharmaceutical Medicine and Translational Clinical Research
Description
Key Features
- 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
Readership
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 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 AuditsSection 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 ResearchSection IV- Pharmaceutical Industry and Intellectual Property Rights
15. Patent
16. Copyright
17. Trademark
18. Trade Secret
19. Data ExclusivitySection 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 BiobettersSection VI- Medical Services
24. Phase IV Studies and Lifecycle Management
25. Medical AffairsSection 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 UMCSection VIII- Drug utilization and Pharmacoeconomics
32. Assessing Medicine Use and Tools for Monitoring Medicine Use
33. Pharmacoeconomics and Healthcare
Product details
- No. of pages: 526
- Language: English
- Copyright: © Academic Press 2017
- Published: November 10, 2017
- Imprint: Academic Press
- Paperback ISBN: 9780128021033
- eBook ISBN: 9780128020982
About the Editors
Divya Vohora
Affiliations and Expertise
Gursharan Singh
Affiliations and Expertise
Ratings and Reviews
Latest reviews
(Total rating for all reviews)
Silvio C. Thu Jun 16 2022
Pharmaceutical Medicine and Translational Clinical Research
Interesting and updating book. I am a MD, and my interest was addressed about the bioequivalence methods on generic versus original medical products. It was a satisfactory result for me about I was looking for.
Monika T. Tue Dec 24 2019
Pharmaceutical Medicine and Translational Clinical Research
Fantastic chapter on Target Product Profile
Shantanu Sun Jan 20 2019
Pharmaceutical Medicine and Translational Clinical Research
Great coverage of Chapters on Biosimilars.
Minto A. Tue Nov 27 2018
Pharmaceutical Medicine and Translational Clinical Research
One of the best book on this complex subject. Everything is explained in such simple words that people from diverse background can understand.