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Post Marketing Clinical Research - REMS, the Latest Reformation due to Post Marketing Surveillance, to Enhance Patient Compliance

  • Published: Sep-2011
  • Report Code: GBIHC094MR
  • Report Format: pdf

Description

List of Figures

Figure 1: Post Marketing Clinical Research, Safety Concept Through Clinical Research 10

Figure 2: Post Marketing Clinical Research, Limitations of Clinical Trials 11

Figure 3: Post Marketing Clinical Research, Assessment of Side Effects - Case Study 15

Figure 4: Post Marketing Clinical Research, Objectives of Post Marketing Clinical Research 20

Figure 5: Post Marketing Clinical Research, Components of Post Marketing Clinical Research 21

Figure 6: Post Marketing Clinical Research, Importance of REMS 23

Figure 7: Post Marketing Clinical Research, Perspective of Pharmacoeconomic Analysis 25

Figure 8: Post Marketing Clinical Research, Types of Pharmacoeconomic Research 26

Figure 9: Post Marketing Clinical Research, Epidemiology Study Designs 28

Figure 10: Post Marketing Clinical Research, Safety Signal Detection Methods 32

Figure 11: Post Marketing Clinical Research, Safety Signal Investigation and Evaluation 33

Figure 12: Post Marketing Clinical Research, Regulatory Provisions of Post Marketing Studies in Children 36

Figure 13: Post Marketing Clinical Research, Issues of Drug Safety in the Elderly - Case Study 39

Figure 14: Post Marketing Clinical Research, Drug Labeling and Pregnancy 41

Figure 15: Post Marketing Clinical Research, Issues of Drug Safety in Pregnant Women - Case Study 42

Figure 16: Post Marketing Clinical Research, Accelerated Approval of Oncology Drugs – Gleevec Case Study 44

Figure 17: Post Marketing Clinical Research, Post Marketing Surveillance of Orphan Drugs – Erbitux Case Study 48

Figure 18: Post Marketing Clinical Research, Post Marketing Surveillance of Vaccines – Rotateq Case Study 49

Figure 19: Post Marketing Clinical Research, Drug Safety Monitoring of Anti-HIV Treatment – Hivid Case Study 51

Figure 20: Post Marketing Clinical Research, Monoclonal Antibodies – Mylotarg Case Study 52

Figure 21: Post Marketing Clinical Research, Monoclonal Antibodies – Rituxan Case Study 53

Figure 22: Post Marketing Clinical Research, Functions of UMC 56

Figure 23: Post Marketing Clinical Research, Important Titles Under FDAAA, 2007 58

Figure 24: Post Marketing Clinical Research, Adverse Event Reports in the US (‘000), 2000-2009 61

Figure 25: Post Marketing Clinical Research, Post Marketing Surveillance System, Japan 70

Figure 26: Post Marketing Clinical Research, Limitations of Outsourcing 77

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