Pharmaceutical Medicine and Translational Clinical Research: This book is written by Divya Vohora and Gursharan Singh. You can download it freely in pdf format. Pharmaceutical Medicine and Clinical Translational Research covers clinical drug testing and the translation of drug research into new drugs, also focusing on the need to understand the safety profile of drugs and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also addressed. It is written clearly and directly to allow quick review and assimilation of complex information and contains easy-to-read features. Since a greater understanding of these issues is essential for students in the areas of pharmaceutical medicine, clinical research, pharmacology, and pharmacy, as well as for professionals working in the pharmaceutical industry, this book is an ideal resource.
The different branches of science are expanding very rapidly and there are vast volumes of new information being discovered and progressively added to current human knowledge. Without a doubt, pharmaceutical sciences are among the most dynamic scientific disciplines that attribute their content to different basic and applied research including studies in the field of physical and organic chemistry, engineering, biochemistry, biology, pharmacology, and medicine. pharmacotherapy. This research aims to understand how to develop new drugs, optimize their delivery to the body, and translate this integrated knowledge into new therapies against human disease, as well as improve community health.
|Book Name||Pharmaceutical Medicine and Translational Clinical Research|
|Author of Book||Divya Vohora and Gursharan|
Overview of Pharmaceutical Medicine and Translational Clinical ResearchAccording 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.
- 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
18. Trade Secret
19. Data Exclusivity
Section V- Generics, Supergenerics, Biologics, biosimilars and bio-betters
20. Generic Drug and Bioequivalence Studies
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
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, 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.
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