Produktbild: Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research

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Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

13.11.2017

Herausgeber

Divya Vohora + weitere

Verlag

Elsevier Science & Technology

Seitenzahl

526

Maße (L/B/H)

23,5/19,5/3 cm

Gewicht

1070 g

Sprache

Englisch

ISBN

978-0-12-802103-3

Beschreibung

Portrait

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.

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

13.11.2017

Herausgeber

Verlag

Elsevier Science & Technology

Seitenzahl

526

Maße (L/B/H)

23,5/19,5/3 cm

Gewicht

1070 g

Sprache

Englisch

ISBN

978-0-12-802103-3

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: Pharmaceutical Medicine and Translational Clinical Research
  • 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