Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research

1st Edition - November 10, 2017

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  • Editors: Divya Vohora, Gursharan Singh
  • Paperback ISBN: 9780128021033
  • eBook ISBN: 9780128020982

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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


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

  • 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

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

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

Ratings and Reviews

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  • 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.