-
1
-
-
84941636370
-
The flaws and human harms of animal experimentation
-
A.Akhtar,, 2015. The flaws and human harms of animal experimentation. Cambridge quarterly of healthcare ethics, 24, 407–419.
-
(2015)
Cambridge quarterly of healthcare ethics
, vol.24
, pp. 407-419
-
-
Akhtar, A.1
-
2
-
-
84977510876
-
Fenclofenac withdrawn
-
Anonymous, 1984. Fenclofenac withdrawn. The lancet, 2, 56.
-
(1984)
The lancet
, vol.2
, pp. 56
-
-
-
4
-
-
77957775831
-
Preventability of drug-related harms - part II: proposed criteria, based on frameworks that classify adverse drug reactions
-
J.K.Aronson, and R.E.Ferner,, 2010. Preventability of drug-related harms - part II: proposed criteria, based on frameworks that classify adverse drug reactions. Drug safety, 33, 995–1002.
-
(2010)
Drug safety
, vol.33
, pp. 995-1002
-
-
Aronson, J.K.1
Ferner, R.E.2
-
5
-
-
1842734345
-
Implementing the precautionary principle: incorporating science, technology, fairness, and accountability in environmental, health, and safety decisions
-
N.A.Ashford,, 2004. Implementing the precautionary principle: incorporating science, technology, fairness, and accountability in environmental, health, and safety decisions. International journal of occupational medicine and environmental health, 17, 59–67.
-
(2004)
International journal of occupational medicine and environmental health
, vol.17
, pp. 59-67
-
-
Ashford, N.A.1
-
6
-
-
0031068049
-
Animal research is wasteful and misleading
-
N.D.Barnard, and S.R.Kaufman,, 1997. Animal research is wasteful and misleading. Scientific American, 276, 80–82.
-
(1997)
Scientific American
, vol.276
, pp. 80-82
-
-
Barnard, N.D.1
Kaufman, S.R.2
-
7
-
-
62749199801
-
Why animal studies are often poor predictors of human reactions to exposure
-
M.B.Bracken,, 2009. Why animal studies are often poor predictors of human reactions to exposure. Journal of the royal society of medicine, 102, 120–122.
-
(2009)
Journal of the royal society of medicine
, vol.102
, pp. 120-122
-
-
Bracken, M.B.1
-
8
-
-
84977559045
-
-
European Commission, 2009. A guideline on summary of product characteristics (SmPC). Available from: http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf [Accessed 15 September 2015].
-
(2009)
-
-
-
9
-
-
84977480446
-
-
European Medicines Agency, 2012. Standard operating procedure. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500003189.pdf [Accessed 15 September 2015].
-
(2012)
-
-
-
10
-
-
0017806118
-
Mammary nodules in beagle dogs administered investigational oral contraceptive steroids
-
R.C.Giles,, et al., 1978. Mammary nodules in beagle dogs administered investigational oral contraceptive steroids. Journal of the national cancer institute, 60, 1351–1364.
-
(1978)
Journal of the national cancer institute
, vol.60
, pp. 1351-1364
-
-
Giles, R.C.1
-
11
-
-
11344266964
-
Alternatives to animal experimentation in basic research
-
F.P.Gruber, and T.Hartung,, 2004. Alternatives to animal experimentation in basic research. Alternatives to animal experiments, 21, 3–31.
-
(2004)
Alternatives to animal experiments
, vol.21
, pp. 3-31
-
-
Gruber, F.P.1
Hartung, T.2
-
12
-
-
77955391449
-
A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group
-
J.J.Guo,, et al., 2010. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value health, 13, 657–666.
-
(2010)
Value health
, vol.13
, pp. 657-666
-
-
Guo, J.J.1
-
13
-
-
84902597896
-
The need for randomization in animal trials: an overview of systematic reviews
-
J.A.Hirst,, et al., 2014. The need for randomization in animal trials: an overview of systematic reviews. PLoS one, 9, e98856.
-
(2014)
PLoS one
, vol.9
, pp. e98856
-
-
Hirst, J.A.1
-
14
-
-
9944262983
-
Risk of cardiovascular events and rofecoxib: cumulative meta-analysis
-
P.Jüni,, et al., 2004. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. The lancet, 364, 2021–2029.
-
(2004)
The lancet
, vol.364
, pp. 2021-2029
-
-
Jüni, P.1
-
15
-
-
84876172734
-
Evidence summaries: the evolution of a rapid review approach
-
S.Khangura,, et al., 2012. Evidence summaries: the evolution of a rapid review approach. Systematic reviews, 1, 10.
-
(2012)
Systematic reviews
, vol.1
, pp. 10
-
-
Khangura, S.1
-
16
-
-
79960983975
-
Thalidomide: the tragedy of birth defects and the effective treatment of disease
-
J.H.Kim, and A.R.Scialli,, 2011. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological sciences, 122, 1–6.
-
(2011)
Toxicological sciences
, vol.122
, pp. 1-6
-
-
Kim, J.H.1
Scialli, A.R.2
-
17
-
-
46749087956
-
Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare
-
A.Knight,, 2008. Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare. Reviews on recent clinical trials, 3, 89–96.
-
(2008)
Reviews on recent clinical trials
, vol.3
, pp. 89-96
-
-
Knight, A.1
-
18
-
-
0018893436
-
Malignant mammary tumors in beagle dogs dosed with investigational oral contraceptive steroids
-
R.P.Kwapien,, et al., 1980. Malignant mammary tumors in beagle dogs dosed with investigational oral contraceptive steroids. Journal of the national cancer institute, 65, 137–144.
-
(1980)
Journal of the national cancer institute
, vol.65
, pp. 137-144
-
-
Kwapien, R.P.1
-
19
-
-
32844475507
-
Case reports of suspected adverse drug reactions-systematic literature survey of follow-up
-
Y.K.Loke,, et al., 2006. Case reports of suspected adverse drug reactions-systematic literature survey of follow-up. British medical journal, 332, 335–339.
-
(2006)
British medical journal
, vol.332
, pp. 335-339
-
-
Loke, Y.K.1
-
20
-
-
84919950805
-
Dissemination bias in systematic reviews of animal research: a systematic review
-
K.F.Mueller,, et al., 2014. Dissemination bias in systematic reviews of animal research: a systematic review. PLoS one, 9, e116016
-
(2014)
PLoS one
, vol.9
, pp. e116016
-
-
Mueller, K.F.1
-
21
-
-
84924082630
-
Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis
-
I.J.Onakpoya,, et al., 2015. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC medicine, 13, 26.
-
(2015)
BMC medicine
, vol.13
, pp. 26
-
-
Onakpoya, I.J.1
-
22
-
-
84959338530
-
Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature
-
I.J.Onakpoya,, et al., 2016. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC medicine, 14(1), 10. doi: 10.1186/s12916-016-0553-2.
-
(2016)
BMC medicine
, vol.14
, Issue.1
, pp. 10
-
-
Onakpoya, I.J.1
-
23
-
-
80053277530
-
-
Oxford Centre for Evidence-Based Medicine
-
OCEBM Levels of Evidence Working Group, 2011. The Oxford 2011 levels of evidence. Oxford Centre for Evidence-Based Medicine. Available from: http://www.cebm.net/index.aspx?o=5653 [Accessed 17 July 2015].
-
(2011)
The Oxford 2011 levels of evidence
-
-
-
24
-
-
11844269320
-
Precautionary principles: a jurisdiction-free framework for decision-making under risk
-
P.F.Ricci,, et al., 2004. Precautionary principles: a jurisdiction-free framework for decision-making under risk. Human & experimental toxicology, 23, 579–600.
-
(2004)
Human & experimental toxicology
, vol.23
, pp. 579-600
-
-
Ricci, P.F.1
-
26
-
-
24644445725
-
The ethical basis of the precautionary principle in health care decision making
-
R.H.ter Meulen,, 2005. The ethical basis of the precautionary principle in health care decision making. Toxicology and applied pharmacology, 207, 663–667.
-
(2005)
Toxicology and applied pharmacology
, vol.207
, pp. 663-667
-
-
ter Meulen, R.H.1
-
27
-
-
84924917599
-
-
Whitehouse Station, NJ: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc
-
The Merck Index, 2013. Encyclopedia of chemicals, drugs, and biologicals. Whitehouse Station, NJ: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc.
-
(2013)
Encyclopedia of chemicals, drugs, and biologicals
-
-
-
28
-
-
0034414637
-
Conclusions. The precautionary principle: its advantages and risks
-
M.Tubiana,, 2000. Conclusions. The precautionary principle: its advantages and risks. Bulletin de l'Académie nationale de médecine, 184, 969–993.
-
(2000)
Bulletin de l'Académie nationale de médecine
, vol.184
, pp. 969-993
-
-
Tubiana, M.1
-
29
-
-
84977488584
-
-
United States Food and Drug Administration (FDA), 2013. Regulatory procedures manual – October 2013. Chapter 7. Recall procedures. Available from: http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf [Accessed 15 September 2015].
-
(2013)
-
-
-
30
-
-
84977578813
-
-
United States Food and Drug Administration (FDA), 2014a. Inside clinical trials: testing medical products in people. Available from: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143531.htm [Accessed 15 September 2015].
-
(2014)
-
-
-
31
-
-
84977501166
-
-
United States Food and Drug Administration (FDA), 2014b. Accelerated approval program. Available from: http://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm [Accessed 17 November 2015].
-
(2014)
-
-
-
32
-
-
84921823783
-
Systematic reviews of animal studies; missing link in translational research?
-
J.van Luijk,, et al., 2014. Systematic reviews of animal studies; missing link in translational research? PLoS one, 9, e89981.
-
(2014)
PLoS one
, vol.9
, pp. e89981
-
-
van Luijk, J.1
-
34
-
-
84977587362
-
-
Wingspread Conference on the Precautionary Principle, 1998. Available from: http://www.sehn.org/wing.html [Accessed 11 November 2015].
-
(1998)
-
-
-
35
-
-
84977569604
-
-
World Health Organization Collaborating Centre for Drug Statistics Methodology (WHO), 2008. Complete ATC/DDD Index. Available from: http://www.whocc.no/atcddd [Accessed 21 April 2013].
-
(2008)
-
-
|