Pharmaceutical Medicine and Translational Clinical Research
Editat de Divya Vohora, Gursharan Singhen Limba Engleză Paperback – 10 noi 2017
- 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
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Specificații
ISBN-13: 9780128021033
ISBN-10: 0128021039
Pagini: 526
Dimensiuni: 191 x 235 x 33 mm
Greutate: 1.13 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128021039
Pagini: 526
Dimensiuni: 191 x 235 x 33 mm
Greutate: 1.13 kg
Editura: ELSEVIER SCIENCE
Public țintă
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.Cuprins
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
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