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Pharmaceutical Medicine and Translational Clinical Research

Specificaties
Paperback, blz. | Engels
Elsevier Science | 2017
ISBN13: 9780128021033
Rubricering
Elsevier Science e druk, 2017 9780128021033
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Samenvatting

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.

Specificaties

ISBN13:9780128021033
Taal:Engels
Bindwijze:Paperback

Inhoudsopgave

<p>Section I- Overview of Pharmaceutical Medicine <br>1. The Specialty of Pharmaceutical Medicine</p> <p>Section II- Drug Discovery and Development <br>2. Drug Discovery and Development: An overview<br>3. Pharmaceutical Development<br>4. Preclinical Drug Development<br>5. Target Product Profile and Clinical Development Plan<br>6. Clinical Pharmacokinetics and Drug Interactions<br>7. Pharmacogenomics: An Evolution Towards Clinical Practice<br>8. Clinical Research Quality Assurance and Audits</p> <p>Section III- Pharmaceutical Law and Ethics <br>9. Pharmaceutical Medicine and Law<br>10. Pharmaceutical Regulations in the United States<br>11. Pharmaceutical Regulations in European Union<br>12. Pharmaceutical Regulations in India<br>13. Pharmaceutical Regulations for Complementary Medicine<br>14. Ethical Considerations in Clinical Research</p> <p>Section IV- Pharmaceutical Industry and Intellectual Property Rights <br>15. Patent<br>16. Copyright<br>17. Trademark<br>18. Trade Secret<br>19. Data Exclusivity</p> <p>Section V- Generics, Supergenerics, Biologics, biosimilars and bio-betters <br>20. Generic Drug and Bioequivalence Studies<br>21. Vaccines<br>22. Biosimilars<br>23. Re-innovation in Pharmaceutical Industry: Supergenerics and Biobetters</p> <p>Section VI- Medical Services <br>24. Phase IV Studies and Lifecycle Management<br>25. Medical Affairs</p> <p>Section VII- Pharmacovigilance <br>26. Pharmacovigilance and Drug Safety<br>27. Clinical and Post Approval Safety Data Management<br>28. Individual Case Safety Reports<br>29. Development and Periodic Safety Reports<br>30. Risk Management in Pharmacovigilance<br>31. Recent Developments in Pharmacovigilance at UMC</p> <p>Section VIII- Drug utilization and Pharmacoeconomics <br>32. Assessing Medicine Use and Tools for Monitoring Medicine Use<br>33. Pharmacoeconomics and Healthcare</p>
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        Pharmaceutical Medicine and Translational Clinical Research