-
1
-
-
84948071507
-
Concept and scope of benefit-risk evaluation of medicines
-
In, Mussen F. Salek S. Walker S. (eds), John Wiley & Sons Ltd Publisher
-
Mussen F, Salek S, Walker S,. 2009. Concept and scope of benefit-risk evaluation of medicines, In In Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision-making (Chapter 1)., Mussen F, Salek S, Walker S, (eds), John Wiley & Sons Ltd Publisher.
-
(2009)
Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision-making (Chapter 1)
-
-
Mussen, F.1
Salek, S.2
Walker, S.3
-
2
-
-
22144474788
-
Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002
-
Wysowski DK, Swartz L,. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002. Arch Intern Med 2005 165: 1363-9.
-
(2005)
Arch Intern Med
, vol.165
, pp. 1363-1369
-
-
Wysowski, D.K.1
Swartz, L.2
-
3
-
-
84889747463
-
-
FDA [Accessed January 2, 2009]
-
FDA. FDA Amendment Act 2007. Available from: [Accessed January 2, 2009].
-
FDA Amendment Act 2007
-
-
-
4
-
-
33646183685
-
How the US drug safety system should be changed
-
DOI 10.1001/jama.295.17.2072
-
Strom BL,. How the US drug safety system should be changed. JAMA 2006 295: 2072-5. (Pubitemid 44794008)
-
(2006)
Journal of the American Medical Association
, vol.295
, Issue.17
, pp. 2072-2075
-
-
Strom, B.L.1
-
5
-
-
30444449389
-
Reform of drug regulation - Beyond an independent drug-safety board
-
DOI 10.1056/NEJMsb053432
-
Ray WA, Stein CM,. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 2006 354: 194-201. (Pubitemid 43076719)
-
(2006)
New England Journal of Medicine
, vol.354
, Issue.2
, pp. 194-201
-
-
Ray, W.A.1
Stein, C.M.2
-
6
-
-
0032890561
-
Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: Applications to highly cited trials in cardiovascular medicine
-
Mancini GBJ, Schulzer M,. Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: applications to highly cited trials in cardiovascular medicine. Circulation 1999 99: 377-83. (Pubitemid 29051263)
-
(1999)
Circulation
, vol.99
, Issue.3
, pp. 377-383
-
-
Mancini, G.B.J.1
Schulzer, M.2
-
7
-
-
11344274277
-
The number needed to treat: A useful clinical measure of a case of the Emperor's new clothes?
-
Grieve AP,. The number needed to treat: a useful clinical measure of a case of the Emperor's new clothes?. Pharmaceutical Statistics 2003 2: 87-102.
-
(2003)
Pharmaceutical Statistics
, vol.2
, pp. 87-102
-
-
Grieve, A.P.1
-
8
-
-
0141505916
-
Benefit-risk analysis: A proposal using quantitative methods
-
DOI 10.1002/pds.887
-
Holden WL, Juhaeri J, Dai W,. Benefit-risk analysis: a proposal using quantitative methods. Pharmacoepidemiololgy Drug Safety 2003 12: 611-16. (Pubitemid 37220648)
-
(2003)
Pharmacoepidemiology and Drug Safety
, vol.12
, Issue.7
, pp. 611-616
-
-
Holden, W.L.1
Juhaeri, J.2
Dai, W.3
-
9
-
-
0347600596
-
Benefit-risk analysis: Examples using quantitative methods
-
DOI 10.1002/pds.794
-
Holden WL, Juhaeri J, Dai W,. Benefit-risk analysis: examples using quantitative methods. Pharmacoepidemiology Drug Safety 2003 12: 693-7. (Pubitemid 38028784)
-
(2003)
Pharmacoepidemiology and Drug Safety
, vol.12
, Issue.8
, pp. 693-697
-
-
Holden, W.L.1
Juhaeri, J.2
Dai, W.3
-
10
-
-
0141839142
-
Benefit-risk analysis: A brief review and proposed quantitative approaches
-
DOI 10.2165/00002018-200326120-00002
-
Holden WL,. Benefit-risk analysis: a brief review and proposed quantitative approaches. Drug Safety 2003 26 (12): 853-862. (Pubitemid 37188248)
-
(2003)
Drug Safety
, vol.26
, Issue.12
, pp. 853-862
-
-
Holden, W.L.1
-
11
-
-
0028221952
-
A new proposal for benefit-less-risk analysis in clinical trials
-
DOI 10.1016/0197-2456(94)90026-4
-
Chuang-Stein C,. A new proposal for benefit-less-risk analysis in clinical trials. Controlled Clinical Trials 1994 15: 30-43. (Pubitemid 24078603)
-
(1994)
Controlled Clinical Trials
, vol.15
, Issue.1
, pp. 30-43
-
-
Chuang-Stein, C.1
-
12
-
-
0025913637
-
Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials
-
Chuang-Stein C,. Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials. Statistics in Medicine 1991 10: 1349-1359.
-
(1991)
Statistics in Medicine
, vol.10
, pp. 1349-1359
-
-
Chuang-Stein, C.1
-
13
-
-
52649127401
-
Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method
-
Pritchett YL, Tamura R,. Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method. Pharmaceutical Statistics 2008 7: 170-8.
-
(2008)
Pharmaceutical Statistics
, vol.7
, pp. 170-178
-
-
Pritchett, Y.L.1
Tamura, R.2
-
15
-
-
50249188726
-
Q-TWiST analysis of lapatinib combined with capecitabine for the treatment of metastatic breast cancer
-
et al
-
Sherrill B, Amonkar MM, Stein S, et al. Q-TWiST analysis of lapatinib combined with capecitabine for the treatment of metastatic breast cancer. Br J Cancer 2008 99: 711-15.
-
(2008)
Br J Cancer
, vol.99
, pp. 711-715
-
-
Sherrill, B.1
Amonkar, M.M.2
Stein, S.3
-
16
-
-
0024536390
-
Costs and benefits of adjuvant therapy in breast cancer: A quality-adjusted survival analysis
-
Goldhirsch A, Gelber RD, Simes RJ, et al. Costs and benefits of adjuvant therapy in breast cancer: a quality-adjusted survival analysis. J Clin Oncol 1989 7: 36-44. (Pubitemid 19089079)
-
(1989)
Journal of Clinical Oncology
, vol.7
, Issue.1
, pp. 36-44
-
-
Goldhirsch, A.1
Gelber, R.D.2
Simes, R.J.3
Glasziou, P.4
Coates, A.S.5
-
17
-
-
0030004351
-
Concepts in risk-benefit assessment. A simple merit analysis of a medicine?
-
Edwards R, Wiholm BE, Martinez C,. Concepts in risk-benefit assessment. A simple merit analysis of a medicine? Drug Saf 1996 15: 89-95.
-
(1996)
Drug Saf
, vol.15
, pp. 89-95
-
-
Edwards, R.1
Wiholm, B.E.2
Martinez, C.3
-
20
-
-
67650596625
-
The clinical utility index as a practical multiattribute approach to drug development decisions
-
Poland B, Hodge FL, Khan A, Clemen RT, Wagner JA, Dykstra K, Krishna R,. The clinical utility index as a practical multiattribute approach to drug development decisions:. Clinical pharmacology & Therapeutics 2009 86: 105-108.
-
(2009)
Clinical Pharmacology & Therapeutics
, vol.86
, pp. 105-108
-
-
Poland, B.1
Hodge, F.L.2
Khan, A.3
Clemen, R.T.4
Wagner, J.A.5
Dykstra, K.6
Krishna, R.7
-
21
-
-
34547543016
-
A quantitative approach to benefit-risk assessment of medicines - Part 1: The development of a new model using multi-criteria decision analysis
-
DOI 10.1002/pds.1435
-
Mussen F, Salek S, Walker S,. A quantitative approach to benefit-risk assessment of medicines-part 1: development of a new model using multi-criteria decision analysis. Pharmacoepidemiology and Drug Safety 2007 16: S2-S15. (Pubitemid 47180358)
-
(2007)
Pharmacoepidemiology and Drug Safety
, vol.16
, Issue.SUPPL. 1
-
-
Mussen, F.1
Salek, S.2
Walker, S.3
-
22
-
-
84889741405
-
A structured health outcomes approach to the pre-marketing quantitative risk-benefit modeling of new pharmaceuticals
-
Office of Health Economics, 24 October 2007, London, UK
-
Garrison L,. A structured health outcomes approach to the pre-marketing quantitative risk-benefit modeling of new pharmaceuticals. Presented at the Benefit-Risk Assessment for Drugs Workshop. Office of Health Economics, 24 October 2007, London, UK.
-
Presented at the Benefit-Risk Assessment for Drugs Workshop
-
-
Garrison, L.1
-
23
-
-
84889726195
-
Quantitative risk-benefit analysis for regulatory decision making: Alternatives and challenges
-
Office of Health Economics, 24 October 2007, London, UK
-
Johnson FR, Hauber AB,. Quantitative risk-benefit analysis for regulatory decision making:Alternatives and challenges. Presented at the Benefit-risk Assessments for Drugs Workshops. Office of Health Economics, 24 October 2007, London, UK.
-
Presented at the Benefit-risk Assessments for Drugs Workshops
-
-
Johnson, F.R.1
Hauber, A.B.2
-
24
-
-
33750629336
-
Joint distribution approaches to simultaneously quantifying benefit and risk
-
Shaffer ML, Watterberg KL,. Joint distribution approaches to simultaneously quantifying benefit and risk. BMC Med Res Methodol 2006 6: 48.
-
(2006)
BMC Med Res Methodol
, vol.6
, pp. 48
-
-
Shaffer, M.L.1
Watterberg, K.L.2
-
25
-
-
5644240874
-
Advances in risk-benefit evaluation using probabilistic simulation methods: An application to the prophylaxis of deep vein thrombosis
-
DOI 10.1016/j.jclinepi.2003.12.012, PII S0895435604000447
-
Lynd LD, O'Brien BJ,. Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis. J Clin Epidemiol 2004 57: 795-803. (Pubitemid 39370162)
-
(2004)
Journal of Clinical Epidemiology
, vol.57
, Issue.8
, pp. 795-803
-
-
Lynd, L.D.1
O'Brien, B.J.2
-
26
-
-
0035962354
-
Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours
-
DOI 10.1016/S0140-6736(00)04522-0
-
Shakespeare TP, Gebski VJ, Veness MJ, Simes J,. Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours. Lancet 2001 357: 1349-53. (Pubitemid 32441538)
-
(2001)
Lancet
, vol.357
, Issue.9265
, pp. 1349-1353
-
-
Shakespeare, T.P.1
Gebski, V.J.2
Veness, M.J.3
Simes, J.4
-
27
-
-
84889714502
-
-
Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW,. A Review of Quantitative Risk-Benefit Methodologies for Assessing Drug Safety and Efficacy-Report of the ISPOR Risk-Benefit Management Working Group Value in Health. 2010. [Epub ahead of print].
-
(2010)
A Review of Quantitative Risk-Benefit Methodologies for Assessing Drug Safety and Efficacy-Report of the ISPOR Risk-Benefit Management Working Group Value in Health. [Epub Ahead of Print]
-
-
Guo, J.J.1
Pandey, S.2
Doyle, J.3
Bian, B.4
Lis, Y.5
Raisch, D.W.6
-
28
-
-
30444449389
-
Reform of drug regulation - Beyond an independent drug-safety board
-
DOI 10.1056/NEJMsb053432
-
Ray WA, Stein CM,. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 2006 354: 194-201. (Pubitemid 43076719)
-
(2006)
New England Journal of Medicine
, vol.354
, Issue.2
, pp. 194-201
-
-
Ray, W.A.1
Stein, C.M.2
-
29
-
-
84856513893
-
Benefit risk assessment during research and development
-
In, Schmitt S. (ed)
-
Schmitt S, Lis Y, Carter M,. 2008. Benefit risk assessment during research and development., In In Risk-Based Compliance Handbook (Chapter 7), Schmitt S, (ed).
-
(2008)
Risk-Based Compliance Handbook (Chapter 7)
-
-
Schmitt, S.1
Lis, Y.2
Carter, M.3
-
30
-
-
15444380375
-
Safety in numbers - Monitoring risk in approved drugs
-
DOI 10.1056/NEJMp058029
-
Okie S,. Safety in numbers-monitoring risk in approved drugs. N Engl J Med 2005 352: 1173-6. (Pubitemid 40397257)
-
(2005)
New England Journal of Medicine
, vol.352
, Issue.12
, pp. 1173-1176
-
-
Okie, S.1
-
31
-
-
0027484162
-
Benefit/risk assessment: What patients can know that scientists cannot
-
Veatch RM,. Benefit risk assessment: what patients can know that scientists cannot. Drug Info J 1993 27: 1021-9. (Pubitemid 23345405)
-
(1993)
Drug Information Journal
, vol.27
, Issue.4
, pp. 1021-1029
-
-
Veatch, R.M.1
-
32
-
-
24044544601
-
Quality-adjusted survival in a crossover trial of letrozole versus tamoxifen in postmenopausal women with advanced breast cancer
-
DOI 10.1093/annonc/mdi275
-
Irish W, Sherrill B, Cole B, Gard C, Glendenning GA, Mouridsen H,. Quality-adjusted survival in a crossover trial of letrozole versus tamoxifen in postmenopausal women with advanced breast cancer. Annals of Oncology 2005 16: 1458-1462. (Pubitemid 41222418)
-
(2005)
Annals of Oncology
, vol.16
, Issue.9
, pp. 1458-1462
-
-
Irish, W.1
Sherrill, B.2
Cole, B.3
Gard, C.4
Glendenning, G.A.5
Mouridsen, H.6
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