-
2
-
-
84959476334
-
-
Benefit-risk methodology project.; 2009. [12 January 2016]
-
European Medicines Agency. Benefit-risk methodology project. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6; 2009. [12 January 2016]
-
-
-
-
4
-
-
84891678894
-
Structured approach to benefit-risk assessment in drug regulatory decision-making.
-
Draft PDUFA V Implementation Plan; 2013. [12 January 2016]
-
Structured approach to benefit-risk assessment in drug regulatory decision-making. Draft PDUFA V Implementation Plan; 2013. Available from: http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf. [12 January 2016]
-
-
-
-
5
-
-
84959462027
-
-
Annex 1 - Grant Agreement N° 115004. PROTECT - Description of work; 2013. [27 August 2014]
-
Annex 1 - Grant Agreement N° 115004. PROTECT - Description of work; 2013. Available from: https://eroombayer.de/eRoom/PH-GDC-PI-SID/IMI-PROTECT/0_10a702. [27 August 2014]
-
-
-
-
6
-
-
84903794459
-
Balancing benefit and risk of medicines: a systematic review and classification of available methodologies
-
Mt-Isa S, Hallgreen CE, Wang N, et al. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf 2014; 23(7): 667-78.
-
(2014)
Pharmacoepidemiol Drug Saf
, vol.23
, Issue.7
, pp. 667-678
-
-
Mt-Isa, S.1
Hallgreen, C.E.2
Wang, N.3
-
9
-
-
78951480208
-
Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines
-
02
-
Coplan PM, Noel RA, Levitan BS, Ferguson J, Mussen F. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clin Pharmacol Ther 2011 02; 89(2): 312-5.
-
(2011)
Clin Pharmacol Ther
, vol.89
, Issue.2
, pp. 312-315
-
-
Coplan, P.M.1
Noel, R.A.2
Levitan, B.S.3
Ferguson, J.4
Mussen, F.5
-
10
-
-
78951477988
-
Application of the BRAT framework to case studies: observations and insights
-
Levitan BS, Andrews EB, Gilsenan A, et al. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther 2011; 89(2): 217-24.
-
(2011)
Clin Pharmacol Ther
, vol.89
, Issue.2
, pp. 217-224
-
-
Levitan, B.S.1
Andrews, E.B.2
Gilsenan, A.3
-
14
-
-
84925882977
-
A survey on stochastic multicriteria acceptability analysis methods
-
Tervonen T, Figueira JR. A survey on stochastic multicriteria acceptability analysis methods. J Multi-Criteria Decis Anal 2008; 15(1-2): 1-14.
-
(2008)
J Multi-Criteria Decis Anal
, vol.15
, Issue.1-2
, pp. 1-14
-
-
Tervonen, T.1
Figueira, J.R.2
-
15
-
-
79955877878
-
A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis
-
Tervonen T, van Valkenhoef G, Buskens E, Hillege HL, Postmus D. A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis. Statist Med 2011; 30(12): 1419-28.
-
(2011)
Statist Med
, vol.30
, Issue.12
, pp. 1419-1428
-
-
Tervonen, T.1
van Valkenhoef, G.2
Buskens, E.3
Hillege, H.L.4
Postmus, D.5
-
16
-
-
0000936944
-
SMAA - stochastic multiobjective acceptability analysis
-
Lahdelma R, Hokkanen J, Salminen P. SMAA - stochastic multiobjective acceptability analysis. Eur J Oper Res 1998; 106(1): 137-43.
-
(1998)
Eur J Oper Res
, vol.106
, Issue.1
, pp. 137-143
-
-
Lahdelma, R.1
Hokkanen, J.2
Salminen, P.3
-
17
-
-
0141505916
-
Benefit-risk analysis: a proposal using quantitative methods
-
Holden WL, Juhaeri J, Dai W. Benefit-risk analysis: a proposal using quantitative methods. Pharmacoepidemiol Drug Saf 2003; 12(7): 611-6.
-
(2003)
Pharmacoepidemiol Drug Saf
, vol.12
, Issue.7
, pp. 611-616
-
-
Holden, W.L.1
Juhaeri, J.2
Dai, W.3
-
18
-
-
0023887476
-
An assessment of clinically useful measures of the consequences of treatment
-
Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318(26): 1728-33.
-
(1988)
N Engl J Med
, vol.318
, Issue.26
, pp. 1728-1733
-
-
Laupacis, A.1
Sackett, D.L.2
Roberts, R.S.3
-
19
-
-
0036073744
-
Impact numbers in health policy decisions
-
Attia J, Page J, Heller RF, Dobson AJ. Impact numbers in health policy decisions. J Epidemiol Community Health 2002; 56(8): 600-5.
-
(2002)
J Epidemiol Community Health
, vol.56
, Issue.8
, pp. 600-605
-
-
Attia, J.1
Page, J.2
Heller, R.F.3
Dobson, A.J.4
-
20
-
-
0036070996
-
Impact numbers: measures of risk factor impact on the whole population from case-control and cohort studies
-
Heller RF, Dobson AJ, Attia J, Page J. Impact numbers: measures of risk factor impact on the whole population from case-control and cohort studies. J Epidemiol Community Health 2002; 56(8): 606-10.
-
(2002)
J Epidemiol Community Health
, vol.56
, Issue.8
, pp. 606-610
-
-
Heller, R.F.1
Dobson, A.J.2
Attia, J.3
Page, J.4
-
21
-
-
0242468694
-
Communicating risks at the population level: application of population impact numbers
-
Heller RF, Buchan I, Edwards R, Lyratzopoulos G, McElduff P, Leger SS. Communicating risks at the population level: application of population impact numbers. BMJ 2003; 327(7424): 1162-5.
-
(2003)
BMJ
, vol.327
, Issue.7424
, pp. 1162-1165
-
-
Heller, R.F.1
Buchan, I.2
Edwards, R.3
Lyratzopoulos, G.4
McElduff, P.5
Leger, S.S.6
-
22
-
-
84857622143
-
Population impact analysis: a framework for assessing the population impact of a risk or intervention
-
Verma A, Torun P, Harris E, et al. Population impact analysis: a framework for assessing the population impact of a risk or intervention. J Public Health (Oxf) 2012; 34(1): 83-9.
-
(2012)
J Public Health (Oxf)
, vol.34
, Issue.1
, pp. 83-89
-
-
Verma, A.1
Torun, P.2
Harris, E.3
-
23
-
-
44649167607
-
Measures for conducting comparative benefit: risk assessment
-
Chuang-Stein C, Entsuah R, Pritchett Y. Measures for conducting comparative benefit: risk assessment. Drug Inf J 2008; 42(3): 223-33.
-
(2008)
Drug Inf J
, vol.42
, Issue.3
, pp. 223-233
-
-
Chuang-Stein, C.1
Entsuah, R.2
Pritchett, Y.3
-
25
-
-
0016527308
-
A survey of the benefits and risks in the practice of radiology
-
Payne JT, Loken MK. A survey of the benefits and risks in the practice of radiology. CRC Crit Rev Clin Radiol Nucl Med 1975; 6(3): 425-39.
-
(1975)
CRC Crit Rev Clin Radiol Nucl Med
, vol.6
, Issue.3
, pp. 425-439
-
-
Payne, J.T.1
Loken, M.K.2
-
26
-
-
33750094121
-
Calculating QALYs, comparing QALY and DALY calculations
-
Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy Plan 2006; 21(5): 402-8.
-
(2006)
Health Policy Plan
, vol.21
, Issue.5
, pp. 402-408
-
-
Sassi, F.1
-
27
-
-
0031709268
-
QALYs versus HYEs-what's right and what's wrong. A review of the controversy
-
Ried W. QALYs versus HYEs-what's right and what's wrong. A review of the controversy. J Health Econ 1998; 17(5): 607-25.
-
(1998)
J Health Econ
, vol.17
, Issue.5
, pp. 607-625
-
-
Ried, W.1
-
28
-
-
21844481778
-
Comparing treatments using quality-adjusted survival: the Q-twist method
-
Gelber RD, Cole BF, Gelber S, Aron G. Comparing treatments using quality-adjusted survival: the Q-twist method. Am Statistician 1995; 49(2): 161-9.
-
(1995)
Am Statistician
, vol.49
, Issue.2
, pp. 161-169
-
-
Gelber, R.D.1
Cole, B.F.2
Gelber, S.3
Aron, G.4
-
29
-
-
0024536390
-
Costs and benefits of adjuvant therapy in breast cancer: a quality-adjusted survival analysis
-
Goldhirsch A, Gelber RD, Simes RJ, Glasziou P, Coates AS. Costs and benefits of adjuvant therapy in breast cancer: a quality-adjusted survival analysis. J Clin Oncol 1989; 7(1): 36-44.
-
(1989)
J Clin Oncol
, 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
-
30
-
-
34248594708
-
Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis
-
Garrison LP, Towse A, Bresnahan BW. Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis. Health Aff (Millwood ) 2007; 26(3): 684-95.
-
(2007)
Health Aff (Millwood )
, vol.26
, Issue.3
, pp. 684-695
-
-
Garrison, L.P.1
Towse, A.2
Bresnahan, B.W.3
-
31
-
-
77954268317
-
Using the incremental net benefit framework for quantitative benefit-risk analysis in regulatory decision-making-a case study of alosetron in irritable bowel syndrome
-
Lynd LD, Najafzadeh M, Colley L, et al. Using the incremental net benefit framework for quantitative benefit-risk analysis in regulatory decision-making-a case study of alosetron in irritable bowel syndrome. Value Health 2010; 13(4): 411-7.
-
(2010)
Value Health
, vol.13
, Issue.4
, pp. 411-417
-
-
Lynd, L.D.1
Najafzadeh, M.2
Colley, L.3
-
32
-
-
1242341330
-
Benefits and harms associated with hormone replacement therapy: clinical decision analysis
-
Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ 2004; 328(7436): 371.
-
(2004)
BMJ
, vol.328
, Issue.7436
, pp. 371
-
-
Minelli, C.1
Abrams, K.R.2
Sutton, A.J.3
Cooper, N.J.4
-
33
-
-
5644240874
-
Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis
-
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(8): 795-803.
-
(2004)
J Clin Epidemiol
, vol.57
, Issue.8
, pp. 795-803
-
-
Lynd, L.D.1
O'Brien, B.J.2
-
34
-
-
41849084193
-
What is the harm-benefit ratio of cox-2 inhibitors?
-
van Staa TP, Smeeth L, Persson I, Parkinson J, Leufkens HG. What is the harm-benefit ratio of cox-2 inhibitors? Int J Epidemiol 2008; 37(2): 405-13.
-
(2008)
Int J Epidemiol
, vol.37
, Issue.2
, pp. 405-413
-
-
van Staa, T.P.1
Smeeth, L.2
Persson, I.3
Parkinson, J.4
Leufkens, H.G.5
-
35
-
-
0037199837
-
Network meta-analysis for indirect treatment comparisons
-
Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med 2002; 21(16): 2313-24.
-
(2002)
Stat Med
, vol.21
, Issue.16
, pp. 2313-2324
-
-
Lumley, T.1
-
36
-
-
5044221416
-
Combination of direct and indirect evidence in mixed treatment comparisons
-
Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med 2004; 23(20): 3105-24.
-
(2004)
Stat Med
, vol.23
, Issue.20
, pp. 3105-3124
-
-
Lu, G.1
Ades, A.E.2
-
37
-
-
33847751838
-
Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis
-
Nixon RM, Bansback N, Brennan A. Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis. Stat Med 2007; 26(6): 1237-54.
-
(2007)
Stat Med
, vol.26
, Issue.6
, pp. 1237-1254
-
-
Nixon, R.M.1
Bansback, N.2
Brennan, A.3
-
39
-
-
0030796960
-
Using conjoint analysis to assess women's preferences for miscarriage management
-
Ryan M, Hughes J. Using conjoint analysis to assess women's preferences for miscarriage management. Health Econ 1997; 6(3): 261-73.
-
(1997)
Health Econ
, vol.6
, Issue.3
, pp. 261-273
-
-
Ryan, M.1
Hughes, J.2
-
41
-
-
85007513810
-
Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines
-
[12 January 2016]
-
Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines; 2013. Available from: http://www.imi-protect.eu/documents/HughesetalRecommendationsforthemethodologyandvisualisationtechniquestobeusedintheassessmento.pdf. [12 January 2016]
-
(2013)
-
-
-
42
-
-
12144254145
-
A bayesian approach to evaluating net clinical benefit allowed for parameter uncertainty
-
Sutton AJ, Cooper NJ, Abrams KR, Lambert PC, Jones DR. A bayesian approach to evaluating net clinical benefit allowed for parameter uncertainty. J Clin Epidemiol 2005; 58(1): 26-40.
-
(2005)
J Clin Epidemiol
, vol.58
, Issue.1
, pp. 26-40
-
-
Sutton, A.J.1
Cooper, N.J.2
Abrams, K.R.3
Lambert, P.C.4
Jones, D.R.5
-
44
-
-
85123459790
-
Benefit-risk modeling of medicinal products: methods and applications
-
In, Sashegyi A, Felli J, Noel R (eds.). CRC Press: Boca Raton, FL
-
Phillips LD. Benefit-risk modeling of medicinal products: methods and applications. In Benefit-risk assessment in pharmaceutical research and development, Sashegyi A, Felli J, Noel R (eds.). CRC Press: Boca Raton, FL, 2013.
-
(2013)
Benefit-risk assessment in pharmaceutical research and development
-
-
Phillips, L.D.1
-
45
-
-
84959560656
-
Review of visualisation methods for the representation of benefit-risk assessment of medication: Stage 2 of 2
-
[Internet]; c2013. [27 August 2014]
-
Review of visualisation methods for the representation of benefit-risk assessment of medication: Stage 2 of 2 [Internet]; c2013. Available from: http://www.imi-protect.eu/documents/ShahruletalReviewofvisualisationmethodsfortherepresentationofBRassessmentofmedicationStage2A.pdf. [27 August 2014]
-
-
-
-
46
-
-
84959457030
-
Literature review of visual representation of the results of benefit-risk assessments of medicinal products
-
Hallgreen C, Mt-Isa S, Lieftucht A, et al. Literature review of visual representation of the results of benefit-risk assessments of medicinal products. Pharmacoepidemiol Drug Saf 2016; 25(3): 238-250.
-
(2016)
Pharmacoepidemiol Drug Saf
, vol.25
, Issue.3
, pp. 238-250
-
-
Hallgreen, C.1
Mt-Isa, S.2
Lieftucht, A.3
-
47
-
-
84959529537
-
-
Final concept paper, 15 December 2010: periodic safety update reports for marketed drugs E2C(R2) and gap and potential improvement analysis of ICH E2C, E2E and E2F.: ICH; 2010. [12 January 2016]
-
ICH. Final concept paper, 15 December 2010: periodic safety update reports for marketed drugs E2C(R2) and gap and potential improvement analysis of ICH E2C, E2E and E2F. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/Concept_papers/E2C_R2__Final_Concept_Paper_December_2010.pdf: ICH; 2010. [12 January 2016]
-
-
-
-
48
-
-
84959475223
-
Benefit-risk in the US regulatory context
-
In, Sashegyi A, Felli J, Noel R (eds.). CRC Press: Boca Raton, FL
-
Franson T, Bonforte P. Benefit-risk in the US regulatory context. In Benefit-risk assessment in pharmaceutical research and development, Sashegyi A, Felli J, Noel R (eds.). CRC Press: Boca Raton, FL, 2013.
-
(2013)
Benefit-risk assessment in pharmaceutical research and development
-
-
Franson, T.1
Bonforte, P.2
-
49
-
-
84959495537
-
-
[12 January 2016]
-
IMI ADVANCE; 2014. Available from: http://www.advance-vaccines.eu/. [12 January 2016]
-
(2014)
-
-
|