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
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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
Author of The Third Histamine Receptor: Selective Ligands as Potential Therapeutic Agents in CNS Disorders, CRC Press, 2008. 130 publications, h-index of 23.
Gursharan Singh, MBBS, Ph.D. (Pharmaceutical Medicine), MIPL started his career as Assistant Professor of Pharmacology at Dolphin Institute, Dehradun, India. He then worked as Senior Medical Affairs and Clinical Research Physician at India's largest Pharmaceutical MNC, the erstwhile Ranbaxy Labs Limited for almost 8 years prior to joining Gurgaon office of a New York based Global Life Sciences Consulting Firm, Smart Analyst as Senior Principal, Life Sciences. Dr Singh has a total of 14 years of experience with almost 12 years of industry experience. His areas of expertise and interest include clinical development strategy, medical affairs, medical writing, new product ideation especially re-innovation including supergenerics and biobetters, orphan drugs and gene therapy. He has contributed to development of target product profile and robust Phase III study design for both New Chemical Entities as well as re-purposed molecules for many Big Pharma and small biotech clients as well as appropriate BE study design for generic drugs. Throughout his career, he has been involved in various training activities in the field of drug development, approval and life cycle management.