230 results on '"Salek, Sam"'
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2. Living with Chronic Disease: Measuring Important Patient-Reported Outcomes
3. Approaches to the Development and Use of PRO Measures: A New Roadmap
4. Applying Modern Test Theory in PRO Measure Development: Rasch modelling
5. Overview
6. Assessing the Performance of PRO Measures Against Expectations: Psychometric Evaluation
7. Integrating PRO Assessment in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes
8. Conceptualisation and Qualitative Development of a PRO Measure
9. Content Validation by Patients and Experts: Is the PRO Measure Fit for Purpose?
10. Drug Testing and the Use of Healthy Volunteers
11. Developing Patient-Reported and Relevant Outcome Measures
12. The Value of Pharmaceutical Innovation: Concepts and Assessment
13. Approaches to Utilizing Decision-Making Framework
14. Proposal for an Improved Centralised Regulatory System
15. Quality Measures in the Gulf Regulatory Practices
16. Overview
17. The Gulf States Assessment and Experience with the Centralised Procedure
18. The Regulatory Dilemma in the Gulf Region: The Way Forward
19. Pharmaceutical Regulatory Environment
20. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers and Solutions
21. The Centralised Regulatory Review in the Gulf Region
22. The Current Status of Drug Safety and Pharmacovigilance
23. The Regulatory Review Process in the Gulf Region
24. Benefit–Risk Assessment of Medicines by Pharmaceutical Companies and Regulatory Authorities
25. The Pharmaceutical Companies Assessment and Experience with the Centralised Procedure
26. Implementation of the Benefit–Risk Summary Template by a Maturing Agency: A Case Study
27. The Current Status of the Common Technical Document
28. Conclusions and Future Directions
29. Regulatory Review Times in the Gulf Region
30. Implementation of the Benefit–Risk Assessment Template by Mature Agencies
31. Overview of Medicines Regulatory Systems in the Gulf Region
32. Benefit-Risk Assessment of Medicines
33. Communicating Benefit–Risk Decisions by US FDA, EMA, TGA, and Health Canada
34. Development of a Universal Benefit–Risk Framework and Template
35. Concept of Major Life-Changing Decisions in Life Course Research
36. Health-related quality of life measurement techniques in the management of dementia
37. Quality of life assessment in dementia research
38. FrontMatter.
39. BackMatter.
40. FrontMatter.
41. Index.
42. Front Matter.
43. Concept and Scope of Benefit-Risk Evaluation of Medicines.
44. Appendix 1: Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit-Risk.
45. Development and Application of a Benefit-Risk Assessment Model Based on Multi-Criteria Decision Analysis.
46. Appendix 5: Forum on Benefit: Risk Decision Analysis - Summary of Discussions and Recommendations - MHRA (September 2008).
47. References.
48. A Future Framework for Benefit-Risk Appraisal of Medicines.
49. Appendix 4: Commentaries on 'A Quantitative Approach to Benefit-Risk Assessment of Medicines' Pharmacoepidemiology and Drug Safety, 2007, 16.
50. Defining a Systematic Approach to Decision Making.
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