-
2
-
-
33645504676
-
Learning from the TGN1412 trial
-
Goodyear M. Learning from the TGN1412 trial. BMJ 2006 332 : 677 78.
-
(2006)
BMJ
, vol.332
, pp. 677-78
-
-
Goodyear, M.1
-
3
-
-
33749648484
-
Establishing risk of human experimentation with drugs: Lessons from TGN1412
-
Kenter MJ, Cohen AF. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 2006 368 : 1387 91.
-
(2006)
Lancet
, vol.368
, pp. 1387-91
-
-
Kenter, M.J.1
Cohen, A.F.2
-
5
-
-
34548029002
-
Note for Guidance on General Considerations for Clinical Trials
-
FDA. 17-12
-
FDA. Note for Guidance on General Considerations for Clinical Trials. Federal Register 62 (242). 17-12-1997.
-
Federal Register
, vol.62
, Issue.242-1997
-
-
-
6
-
-
0034040719
-
Pharmacokinetics, COX-2 specificity, and tolerability of supratherapeutic doses of rofecoxib in humans
-
Depre M, Ehrich E, Van Hecken A, De Lepeleire, Dallob A, Wong P, Porras A, Gertz BJ, De Shepper PJ. Pharmacokinetics, COX-2 specificity, and tolerability of supratherapeutic doses of rofecoxib in humans. Eur J Clin Pharmacol 2000 56 : 167 74.
-
(2000)
Eur J Clin Pharmacol
, vol.56
, pp. 167-74
-
-
Depre, M.1
Ehrich, E.2
Van Hecken Lepeleire A.De3
Dallob, A.4
Wong, P.5
Porras, A.6
Gertz, B.J.7
De Shepper, P.J.8
-
7
-
-
0033730933
-
A new cyclooxygenase-2 inhibitor, rofecoxib (VIOXX), did not alter the antiplatelet effects of low-dose aspirin in healthy volunteers
-
Greenberg HE, Gottesdiener K, Huntington M, Wong P, Larson P, Wildonger L, Gillen L, Dorval E, Waldman SA. A new cyclooxygenase-2 inhibitor, rofecoxib (VIOXX), did not alter the antiplatelet effects of low-dose aspirin in healthy volunteers. J Clin Pharmacol 2000 40 : 1509 15.
-
(2000)
J Clin Pharmacol
, vol.40
, pp. 1509-15
-
-
Greenberg, H.E.1
Gottesdiener, K.2
Huntington, M.3
Wong, P.4
Larson, P.5
Wildonger, L.6
Gillen, L.7
Dorval, E.8
Waldman, S.A.9
-
8
-
-
0031855536
-
Pharmacokinetics and pharmacodynamics after oral and intravenous administration of tolcapone, a novel adjunct to Parkinson's disease therapy
-
Jorga KM, Fotteler B, Heizmann P, Zurcher G. Pharmacokinetics and pharmacodynamics after oral and intravenous administration of tolcapone, a novel adjunct to Parkinson's disease therapy. Eur J Clin Pharmacol 1998 54 : 443 47.
-
(1998)
Eur J Clin Pharmacol
, vol.54
, pp. 443-47
-
-
Jorga, K.M.1
Fotteler, B.2
Heizmann, P.3
Zurcher, G.4
-
9
-
-
0034642347
-
COMT inhibitors and liver toxicity
-
S52.
-
Watkins P. COMT inhibitors and liver toxicity. Neurology 2000 55 : S51 S52.
-
(2000)
Neurology
, vol.55
-
-
Watkins, P.1
-
10
-
-
0042329133
-
Cerivastatin monotherapy-induced muscle weakness, rhabdomyolysis and acute renal failure
-
Bakri R, Wang J, Wierzbicki AS, Goldsmith D. Cerivastatin monotherapy-induced muscle weakness, rhabdomyolysis and acute renal failure. Int J Cardiol 2003 91 : 107 109.
-
(2003)
Int J Cardiol
, vol.91
, pp. 107-109
-
-
Bakri, R.1
Wang, J.2
Wierzbicki, A.S.3
Goldsmith, D.4
-
11
-
-
0032572716
-
Preclinical and clinical pharmacology of cerivastatin. Am
-
Bischoff H, Heller AH. Preclinical and clinical pharmacology of cerivastatin. Am J Cardiol 1998 82 : 18J 25J.
-
(1998)
J Cardiol
, vol.82
-
-
Bischoff, H.1
Heller, A.H.2
-
12
-
-
33644974597
-
Stroke prevention using the oral direct thrombin inhibitor ximelagatran in patients with non-valvular atrial fibrillation. Pooled analysis from the SPORTIF III and V studies
-
Diener HC. Stroke prevention using the oral direct thrombin inhibitor ximelagatran in patients with non-valvular atrial fibrillation. Pooled analysis from the SPORTIF III and V studies. Cerebrovasc Dis 2006 21 : 279 93.
-
(2006)
Cerebrovasc Dis
, vol.21
, pp. 279-93
-
-
Diener, H.C.1
-
13
-
-
31344453249
-
Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men
-
Wernevik LC, Nystrom P, Johnsson G, Nakanishi T, Eriksson UG. Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men. Clin Pharmacokinet 2006 45 : 77 84.
-
(2006)
Clin Pharmacokinet
, vol.45
, pp. 77-84
-
-
Wernevik, L.C.1
Nystrom, P.2
Johnsson, G.3
Nakanishi, T.4
Eriksson, U.G.5
-
14
-
-
0345257262
-
Joining the DoTS: New approach to classifying adverse drug reactions
-
Aronson JK, Ferner RE. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ 2003 327 : 1222 5.
-
(2003)
BMJ
, vol.327
, pp. 1222-5
-
-
Aronson, J.K.1
Ferner, R.E.2
-
15
-
-
0030852662
-
Pharmacokinetics of RheothRx injection in healthy male volunteers
-
Jewell RC, Khor SP, Kisor DF, LaCroix KA, Wargin WA. Pharmacokinetics of RheothRx injection in healthy male volunteers. J Pharm Sci 1997 86 : 808 12.
-
(1997)
J Pharm Sci
, vol.86
, pp. 808-12
-
-
Jewell, R.C.1
Khor, S.P.2
Kisor, D.F.3
Lacroix, K.A.4
Wargin, W.A.5
-
16
-
-
0030789176
-
Effects of RheothRx on mortality, morbidity, left ventricular function, and infarct size in patients with acute myocardial infarction. Collaborative Organization for RheothRx Evaluation (CORE)
-
CORE trial group.
-
CORE trial group. Effects of RheothRx on mortality, morbidity, left ventricular function, and infarct size in patients with acute myocardial infarction. Collaborative Organization for RheothRx Evaluation (CORE). Circulation 1997 96 : 192 201.
-
(1997)
Circulation
, vol.96
, pp. 192-201
-
-
-
17
-
-
0031836168
-
Randomized, controlled trial of RheothRx (poloxamer 188) in patients with suspected acute myocardial infarction. RheothRx in Myocardial Infarction Study Group
-
Maynard C, Swenson R, Paris JA, Martin JS, Hallstrom AP, Cerqueira MD, Weaver WD. Randomized, controlled trial of RheothRx (poloxamer 188) in patients with suspected acute myocardial infarction. RheothRx in Myocardial Infarction Study Group. Am Heart J 1998 135 : 797 804.
-
(1998)
Am Heart J
, vol.135
, pp. 797-804
-
-
Maynard, C.1
Swenson, R.2
Paris, J.A.3
Martin, J.S.4
Hallstrom, A.P.5
Cerqueira, M.D.6
Weaver, W.D.7
-
20
-
-
34548049564
-
-
Parexel. 21-12-2006. London.
-
Parexel. Parexel Clinical Trial Protocol- A phase I single-centre, double blind, randomized, placebo-controlled, single escalating dose study to assess the safety, pharmacokinetics, pharmacodynamics and immunogenicity of TGN1412 administered intravenously to healthy volunteers. 21-12-2006. London.
-
Parexel Clinical Trial Protocol- A Phase I Single-centre, Double Blind, Randomized, Placebo-controlled, Single Escalating Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of TGN1412 Administered Intravenously to Healthy Volunteers
-
-
-
22
-
-
33645983683
-
Inquiry into adverse events in trial blames drug, not study design
-
Mayor S. Inquiry into adverse events in trial blames drug, not study design. BMJ 2006 332 : 870.
-
(2006)
BMJ
, vol.332
, pp. 870
-
-
Mayor, S.1
-
23
-
-
0021812652
-
Limitations of dose tolerance studies on predictability for phase III
-
Warrington SJ. Limitations of dose tolerance studies on predictability for phase III. Arzneimittelforschung. 1985 35 : 781 3.
-
(1985)
Arzneimittelforschung.
, vol.35
, pp. 781-3
-
-
Warrington, S.J.1
-
24
-
-
0028792083
-
First-time-in-human dose selection: Allometric thoughts and perspectives
-
Boxenbaum H, DiLea C. First-time-in-human dose selection: allometric thoughts and perspectives. J Clin Pharmacol 1995 35 : 957 66.
-
(1995)
J Clin Pharmacol
, vol.35
, pp. 957-66
-
-
Boxenbaum, H.1
Dilea, C.2
-
25
-
-
34250664524
-
Dose escalating safety study of CNS 5161 HCl, a new neuronal glutamate receptor antagonist (NMDA) for the treatment of neuropathic pain
-
Forst T, Smith T, Schutte K, Marcus P, Pfutzner A. Dose escalating safety study of CNS 5161 HCl, a new neuronal glutamate receptor antagonist (NMDA) for the treatment of neuropathic pain. Br J Clin Pharmacol 2007 63 : 75 82.
-
(2007)
Br J Clin Pharmacol
, vol.63
, pp. 75-82
-
-
Forst, T.1
Smith, T.2
Schutte, K.3
Marcus, P.4
Pfutzner, A.5
-
26
-
-
34548031359
-
The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects
-
Stangier J, Rathgen K, Stahle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007 64 : 292 303.
-
(2007)
Br J Clin Pharmacol
, vol.64
, pp. 292-303
-
-
Stangier, J.1
Rathgen, K.2
Stahle, H.3
Gansser, D.4
Roth, W.5
-
27
-
-
34548027952
-
Single and multiple ascending dose studies of a novel tissue-selective oestrogen receptor modulator, CHF 4227, in healthy postmenopausal women
-
Civelli M, Preti AP, Cenacchi V, Cenacchi V, Rondelli I, Guastalla D, Tarral A, Dostert P, Guillevic, Homery MC. Single and multiple ascending dose studies of a novel tissue-selective oestrogen receptor modulator, CHF 4227, in healthy postmenopausal women. Br J Clin Pharmacol 2007 64 : 304 16.
-
(2007)
Br J Clin Pharmacol
, vol.64
, pp. 304-16
-
-
Civelli, M.1
Preti, A.P.2
Cenacchi, V.3
Cenacchi, V.4
Rondelli, I.5
Guastalla, D.6
Tarral, A.7
Dostert P.Guillevic8
Homery, M.C.9
-
28
-
-
9844226779
-
Integrated pharmacokinetics and pharmacodynamics of Ro 48-6791, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects
-
Dingemanse J, van Gerven JM, Schoemaker RC, Roncari G, Oberye JJ, van Oostenbruggen MF, Massarella J, Segala P, Zell M, Cohen AF. Integrated pharmacokinetics and pharmacodynamics of Ro 48-6791, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects. Br J Clin Pharmacol 1997 44 : 477 86.
-
(1997)
Br J Clin Pharmacol
, vol.44
, pp. 477-86
-
-
Dingemanse, J.1
Van Gerven, J.M.2
Schoemaker, R.C.3
Roncari, G.4
Oberye, J.J.5
Van Oostenbruggen, M.F.6
Massarella, J.7
Segala, P.8
Zell, M.9
Cohen, A.F.10
-
29
-
-
9844226779
-
Integrated pharmacokinetics and pharmacodynamics of Ro 48-8684, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects
-
van Gerven JM, Roncari G, Schoemaker RC, Massarella J, Keesmaat P, Kooyman H, Heizmann P, Zell M, Cohen AF, Dingemanse J. Integrated pharmacokinetics and pharmacodynamics of Ro 48-8684, a new benzodiazepine, in comparison with midazolam during first administration to healthy male subjects. Br J Clin Pharmacol 1997 44 : 487 93.
-
(1997)
Br J Clin Pharmacol
, vol.44
, pp. 487-93
-
-
Van Gerven, J.M.1
Roncari, G.2
Schoemaker, R.C.3
Massarella, J.4
Keesmaat, P.5
Kooyman, H.6
Heizmann, P.7
Zell, M.8
Cohen, A.F.9
Dingemanse, J.10
-
30
-
-
34548040413
-
Scottish GPs use of homeopathy
-
Leckridge R. Scottish GPs use of homeopathy. Br J Clin Pharmacol 2007 64 : 397.
-
(2007)
Br J Clin Pharmacol
, vol.64
, pp. 397
-
-
Leckridge, R.1
-
31
-
-
34548029362
-
Homeopathy is safe and does not lack positive evidence in clinical trials
-
Mathie RT, Fisher P. Homeopathy is safe and does not lack positive evidence in clinical trials. Br J Clin Pharmacol 2007 64 : 396.
-
(2007)
Br J Clin Pharmacol
, vol.64
, pp. 396
-
-
Mathie, R.T.1
Fisher, P.2
|