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Elsevier

Pharmaceutical Medicine and Translational Clinical Research

  • 1st Edition - November 10, 2017
  • Latest edition
  • Editors: Divya Vohora, Gursharan Singh
  • Language: English

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusi… Read more

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.

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

Graduate and postgraduate students in the areas of clinical research, pharmaceutical medicine, clinical pharmacology and pharmacy, as well as professors teaching in these areas; also professionals working in the pharmaceutical industry or contract research organizations and drug regulatory authorities

Table of contents

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

Product details

  • Edition: 1
  • Latest edition
  • Published: November 13, 2017
  • Language: English

About the editors

DV

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.
Affiliations and expertise
Professor, Pharmaceutical Medicine, In charge of Neurobehavioral Pharmacology Lab, Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India

GS

Gursharan Singh

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.
Affiliations and expertise
Senior Principal, SmartAnalyst India Private Limited, Gurgaon, India

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