Pharmaceutical Medicine and Translational Clinical Research Pdf Free

Overview of Pharmaceutical Medicine and Translational Clinical Research

According to Divya Vohora and Gursharan, Although in the recent past, the main emphasis was on integrating advances in the biomedical field with clinical practice, that is, taking research from the “bench” to the “bed”, however, today, “translational medicine” places emphasis on the translation of basic scientific findings at the bench into potential treatments for disease and to improve public health, where a combination of disciplines, resources, expertise, and techniques must be applied within the three main pillars of “bench”, ” bedside” and “community” to support developments in disease prevention, diagnosis, and therapy. This is where economic evaluations and marketing are also important parts of translational research.

In the field of pharmaceutical research, bidirectional interdisciplinary and intradisciplinary relationships exist between and within the main pillars of translational research. Molecular and preclinical laboratory information obtained in the laboratory along with findings obtained in human and clinical studies should be scientifically understood and interpreted as aggregate evidence. These should eventually be integrated with feedback from community-based clinical practice leading to more efficient discoveries that benefit healthcare systems. Clinical observations on the nature, pathogenesis, and development of diseases, as well as responses and complications caused by therapies, can effectively drive basic scientific research. Knowledge gained from basic science provides clinicians with new treatment strategies. Hopefully, this ongoing cycle of translational research may result in more rational drug design, increased efficacy of therapeutic agents, and accelerated optimization of investigational compounds for clinical use, which can ultimately be used in the field of medicine. public health. Furthermore, this will lead to a more cost-effective drug discovery process.

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

Topics of this Edition

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

About the Author

Divya Vohora
Author of The Third Histamine Receptor: Selective Ligands as Potential Therapeutic Agents in CNS Disorders, CRC Press, 2008. 130 publications, h-index of 23.
Professor, Pharmaceutical Medicine, In charge of the Laboratory of Neurobehavioral Pharmacology, Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
Gursharan Singh
Gursharan Singh, MBBS, Ph.D. (Pharmaceutical Medicine), MIPL began his career as an Assistant Professor of Pharmacology at the Dolphin Institute, Dehradun, India. He then worked as a Senior Medical Affairs and Clinical Research Physician at India’s largest multinational pharmaceutical company, the former Ranbaxy Labs Limited, for almost 8 years before joining the Gurgaon office of a global life sciences consulting firm with Headquartered in New York, Smart Analyst as Senior Director of Life Sciences. . Dr. Singh has a total of 14 years of experience with nearly 12 years of experience in the industry. His areas of expertise and interest include clinical development strategy, medical affairs, medical writing, new product ideation, especially reinnovation, including supergenerics and bioenhancers, orphan drugs, and gene therapy. He has contributed to target product profile development and robust Phase III study design for both new chemical entities and repurposed 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.