-
1
-
-
77955947721
-
Safety pharmacology studies for human pharmaceuticals S7A
-
Available from
-
ICH Harmonised Tripartite Guideline. Safety pharmacology studies for human pharmaceuticals S7A. 2000. Available from: www.ich.org/LOB/ media/MEDIA504.pdf
-
(2000)
ICH Harmonised Tripartite Guideline
-
-
-
2
-
-
77955948001
-
The non-clinical evaluation of the potential for delayed ventricular repolarization QT interval prolongation by human pharmaceuticals. S7B
-
Available from
-
ICH Harmonised Tripartite Guideline. The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. S7B. 2005. Available from: www.ich.org/LOB/ media/MEDIA2192.pdf
-
(2005)
ICH Harmonised Tripartite Guideline
-
-
-
3
-
-
77955960679
-
-
Available from
-
Available from: www.redbio.org/portal/ encuentros/enc-2001/conferencias/ C-23%20Pendiente%20en%20 conferencias/C-23.pdf
-
-
-
-
4
-
-
74949112537
-
Resting heart rate pattern during follow-up and mortality in hypertensive patients
-
Paul L, Hastie CE, Li WS, et al. Resting heart rate pattern during follow-up and mortality in hypertensive patients. Hypertension 2010;55:567-574
-
(2010)
Hypertension
, vol.55
, pp. 567-574
-
-
Paul, L.1
Hastie, C.E.2
Li, W.S.3
-
5
-
-
84971580244
-
Absence of evidence is not evidence of absence
-
Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ 1995;311(7003):485
-
(1995)
BMJ
, vol.311
, Issue.7003
, pp. 485
-
-
Altman, D.G.1
Bland, J.M.2
-
6
-
-
77955931471
-
Cardiovascular safety assessments in the conscious telemetered dog: Utilisation of super-intervals to enhance statistical power
-
press
-
Sivarajah A, Collins S, Sutton M, et al. Cardiovascular safety assessments in the conscious telemetered dog: utilisation of super-intervals to enhance statistical power. J Pharmacol Toxicol Methods 2010; In press
-
(2010)
J. Pharmacol. Toxicol. Methods
-
-
Sivarajah, A.1
Collins, S.2
Sutton, M.3
-
7
-
-
70449461523
-
Exploratory safety pharmacology: A new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations
-
Cavero I. Exploratory safety pharmacology: a new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations. Expert Opin Drug Saf 2009;8:627-647
-
(2009)
Expert. Opin. Drug. Saf.
, vol.8
, pp. 627-647
-
-
Cavero, I.1
-
8
-
-
0344492207
-
Relationships between preclinical cardiac electrophysiology clinical QT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety margin in drug development
-
Redfern WS, Carlsson L, Davis AS, et al. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res 2003;58:32-45
-
(2003)
Cardiovasc Res.
, vol.58
, pp. 32-45
-
-
Redfern, W.S.1
Carlsson, L.2
Davis, A.S.3
-
9
-
-
0036234833
-
Towards a drug concentration effect relationship for QT prolongation and torsades de pointes
-
Webster R, Leishman D, Walker D. Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr Opin Drug Discov Dev 2002;5:116-126
-
(2002)
Curr. Opin. Drug. Discov. Dev.
, vol.5
, pp. 116-126
-
-
Webster, R.1
Leishman, D.2
Walker, D.3
-
10
-
-
74549140187
-
Integrated risk assessment and predictive value to humans of non-clinical repolarization assays
-
Wallis RM. Integrated risk assessment and predictive value to humans of non-clinical repolarization assays. Br J Pharmacol 2010;159:115-121
-
(2010)
Br. J. Pharmacol.
, vol.159
, pp. 115-121
-
-
Wallis, R.M.1
-
12
-
-
33845194767
-
A rabbit Langendorff heart proarrhythmia model: Predictive value for clinical identification of Torsades de Pointes
-
Lawrence CL, Bridgland-Taylor MH, Pollard CE, et al. A rabbit Langendorff heart proarrhythmia model: predictive value for clinical identification of Torsades de Pointes. Br J Pharmacol 2006;149:845-860
-
(2006)
Br. J. Pharmacol.
, vol.149
, pp. 845-860
-
-
Lawrence, C.L.1
Bridgland-Taylor, M.H.2
Pollard, C.E.3
-
13
-
-
33645062178
-
PRODACT: In vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals
-
Toyoshima S, Kanno A, Kitayama T, et al. PRODACT: in vivo QT assay in the conscious dog for assessing the potential for QT interval prolongation by human pharmaceuticals. J Pharmacol Sci 2005;99:459-471
-
(2005)
J. Pharmacol. Sci.
, vol.99
, pp. 459-471
-
-
Toyoshima, S.1
Kanno, A.2
Kitayama, T.3
-
14
-
-
33747887172
-
ILSI-HESI cardiovascular safety subcommittee initiative: Evaluation of three non-clinical models of QT prolongation
-
Hanson LA, Bass AS, Gintant G, et al. ILSI-HESI cardiovascular safety subcommittee initiative: evaluation of three non-clinical models of QT prolongation. J Pharmacol Toxicol Methods 2006;54:116-129
-
(2006)
J. Pharmacol. Toxicol. Methods
, vol.54
, pp. 116-129
-
-
Hanson, L.A.1
Bass, A.S.2
Gintant, G.3
-
15
-
-
77953956128
-
Machine learning algorithms for the prediction of hERG and CYP450 binding in drug development
-
Klon AE. Machine learning algorithms for the prediction of hERG and CYP450 binding in drug development. Expert Opin Drug Metab Toxicol 2010;6:821-833
-
(2010)
Expert. Opin. Drug. Metab. Toxicol.
, vol.6
, pp. 821-833
-
-
Klon, A.E.1
-
16
-
-
68749083601
-
A framework to assess the translation of safety pharmacology data to humans
-
Valentin JP, Bialecki R, Ewart L, et al. A framework to assess the translation of safety pharmacology data to humans. J Pharmacol Toxicol Methods 2009;60:152-158
-
(2009)
J. Pharmacol. Toxicol. Methods
, vol.60
, pp. 152-158
-
-
Valentin, J.P.1
Bialecki, R.2
Ewart, L.3
-
17
-
-
68749117480
-
A HESI consortium approach to assess the human predictive value of non-clinical repolarization assays
-
HESI Pro-Arrhythmia Committee
-
Trepakova ES, Koerner J, Pettit SD, et al. HESI Pro-Arrhythmia Committee. A HESI consortium approach to assess the human predictive value of non-clinical repolarization assays. J Pharmacol Toxicol Methods 2009;60:45-50
-
(2009)
J. Pharmacol. Toxicol. Methods
, vol.60
, pp. 45-50
-
-
Trepakova, E.S.1
Koerner, J.2
Pettit, S.D.3
-
18
-
-
0036570099
-
Timing of new black box warnings and withdrawals for prescription medications
-
Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287:2215-2220
-
(2002)
JAMA
, vol.287
, pp. 2215-2220
-
-
Lasser, K.E.1
Allen, P.D.2
Woolhandler, S.J.3
-
19
-
-
68949149740
-
Current challenges in the evaluation of cardiac safety during drug development: Translational medicine meets the Critical Path Initiative
-
Piccini JP, Whellan DJ, Berridge BR, et al. Current challenges in the evaluation of cardiac safety during drug development: translational medicine meets the Critical Path Initiative. Am Heart J 2009;158:317-326
-
(2009)
Am. Heart J.
, vol.158
, pp. 317-326
-
-
Piccini, J.P.1
Whellan, D.J.2
Berridge, B.R.3
-
20
-
-
33846886709
-
Novel probabilistic method for precisely correcting the QT interval for heart rate in telemetered dogs andcynomolgus monkeys
-
Holzgrefe HH, Cavero I, Gleason CR, et al. Novel probabilistic method for precisely correcting the QT interval for heart rate in telemetered dogs andcynomolgus monkeys. J Pharmacol Toxicol Methods 2007;55:159-175
-
(2007)
J. Pharmacol. Toxicol. Methods
, vol.55
, pp. 159-175
-
-
Holzgrefe, H.H.1
Cavero, I.2
Gleason, C.R.3
-
21
-
-
33947238203
-
Application of a probabilistic method for the determination of drug-induced QT prolongation in telemetered cynomolgus monkeys: Effects of moxifloxacin
-
Holzgrefe HH, Cavero I, Buchanan LV, et al. Application of a probabilistic method for the determination of drug-induced QT prolongation in telemetered cynomolgus monkeys: effects of moxifloxacin. J Pharmacol Toxicol Methods 2007;55:227-237
-
(2007)
J. Pharmacol. Toxicol. Methods
, vol.55
, pp. 227-237
-
-
Holzgrefe, H.H.1
Cavero, I.2
Buchanan, L.V.3
-
23
-
-
48149083114
-
The effect of changes in core body temperature on the QT interval in beagle dogs: A previously ignored phenomenon with a method for correction\
-
Van Der Linde HJ, Van Deuren B, Teisman A, et al. The effect of changes in core body temperature on the QT interval in beagle dogs: a previously ignored phenomenon, with a method for correction. Br J Pharmacol 2008;154:1474-1481
-
(2008)
Br. J. Pharmacol.
, vol.154
, pp. 1474-1481
-
-
Van Der Linde, H.J.1
Van Deuren, B.2
Teisman, A.3
-
24
-
-
77649177607
-
9th Annual Meeting
-
Safety Pharmacology Society:
-
Cavero I. Safety Pharmacology Society: 9th Annual Meeting. Expert Opin Drug Saf 2010;9:365-378
-
(2010)
Expert. Opin. Drug. Saf.
, vol.9
, pp. 365-378
-
-
Cavero, I.1
-
25
-
-
77955937198
-
The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs E14
-
Available from
-
ICH Harmonised Tripartite Guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs E14. Available from: www.ich.org/LOB/ media/MEDIA1476.pdf
-
ICH Harmonised Tripartite Guideline
-
-
-
26
-
-
58849132807
-
The future of drug safety testing: Expanding the view and narrowing the focus
-
Stevens JL, Baker TK. The future of drug safety testing: expanding the view and narrowing the focus. Drug Discov Today 2009;14:162-167
-
(2009)
Drug. Discov. Today.
, vol.14
, pp. 162-167
-
-
Stevens, J.L.1
Baker, T.K.2
-
27
-
-
73449101512
-
Lessons from 60 years of pharmaceutical innovation
-
Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 2009;8:959-968
-
(2009)
Nat. Rev. Drug. Discov.
, vol.8
, pp. 959-968
-
-
Munos, B.1
-
28
-
-
77649234756
-
How to improve R&D productivity: The pharmaceutical industrys grand challenge
-
Paul SM, Mytelka DS, Dunwiddie CT, et al. How to improve R&D productivity: the pharmaceutical industrys grand challenge. Nat Rev Drug Discov 2010;9:203-214
-
(2010)
Nat. Rev. Drug. Discov.
, vol.9
, pp. 203-214
-
-
Paul, S.M.1
Mytelka, D.S.2
Dunwiddie, C.T.3
-
29
-
-
77249096313
-
Prediction of drug-related cardiac adverse effects in humans-A: Creation of a database of effects and identification of factors affecting their occurrence
-
Matthews EJ, Frid AA. Prediction of drug-related cardiac adverse effects in humans-A: creation of a database of effects and identification of factors affecting their occurrence. Regul Toxicol Pharmacol 2010;56:247-275
-
(2010)
Regul. Toxicol. Pharmacol.
, vol.56
, pp. 247-275
-
-
Matthews, E.J.1
Frid, A.A.2
-
30
-
-
77249175263
-
Prediction of drug-related cardiac adverse effects in humans-B: Use of QSAR programs for early detection of drug-induced cardiac toxicities
-
Frid AA, Matthews EJ. Prediction of drug-related cardiac adverse effects in humans-B: use of QSAR programs for early detection of drug-induced cardiac toxicities. Regul Toxicol Pharmacol 2010;56:276-289
-
(2010)
Regul. Toxicol. Pharmacol.
, vol.56
, pp. 276-289
-
-
Frid, A.A.1
Matthews, E.J.2
-
31
-
-
77953920763
-
Regulatory use of computational toxicology tools and databases at the United States food and drug administrations office of food additive safety
-
Kirk B, Arvidson KB, Ronald Chanderbhan R, et al. Regulatory use of computational toxicology tools and databases at the United States Food and Drug Administrations Office of Food Additive Safety. Expert Opin Drug Metab Toxicol 2010;6:821-833
-
(2010)
Expert. Opin. Drug. Metab. Toxicol.
, vol.6
, pp. 821-833
-
-
Kirk, B.1
Arvidson, K.B.2
Ronald Chanderbhan, R.3
|