-
1
-
-
0018079909
-
Clinically significant adverse effects in a phase 1 testing program
-
Zarafonetis CJ, Riley Jr PA, Willis III PW, et al. Clinically significant adverse effects in a phase 1 testing program. Clin Pharmacol Ther 1978; 24 (2): 127-32
-
(1978)
Clin Pharmacol Ther
, vol.24
, Issue.2
, pp. 127-132
-
-
Zarafonetis, C.J.1
Riley Jr, P.A.2
Willis III, P.W.3
-
2
-
-
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 (9544): 1387-91
-
(2006)
Lancet
, vol.368
, Issue.9544
, pp. 1387-1391
-
-
Kenter, M.J.1
Cohen, A.F.2
-
3
-
-
0037186921
-
Protecting research subjects: The crisis at Johns Hopkins
-
Steinbrook R. Protecting research subjects: the crisis at Johns Hopkins. N Engl J Med 2002; 346 (9): 716-20
-
(2002)
N Engl J Med
, vol.346
, Issue.9
, pp. 716-720
-
-
Steinbrook, R.1
-
4
-
-
84920232537
-
Sudden death of a volunteer
-
Darragh A, Kenny M, Lambe R, et al. Sudden death of a volunteer. Lancet 1985; 1 (8420): 93-4
-
(1985)
Lancet
, vol.1
, Issue.8420
, pp. 93-94
-
-
Darragh, A.1
Kenny, M.2
Lambe, R.3
-
5
-
-
43649100311
-
-
US FDA. International conference on harmonization; guidance on general considerations for clinical trials [online]. Fed Regist 1997 Dec 17; 62 (242): 66113-9. Available from URL: http://frwebgate.access.gpo.gov/cgi-bin/get-doc. cgi?dbname=1997_register&docid=fr17de97-92.pdf [Accessed 2008 Feb 16]
-
US FDA. International conference on harmonization; guidance on general considerations for clinical trials [online]. Fed Regist 1997 Dec 17; 62 (242): 66113-9. Available from URL: http://frwebgate.access.gpo.gov/cgi-bin/get-doc. cgi?dbname=1997_register&docid=fr17de97-92.pdf [Accessed 2008 Feb 16]
-
-
-
-
6
-
-
0031003468
-
Learning versus confirming in clinical drug development
-
Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997; 61 (3): 275-91
-
(1997)
Clin Pharmacol Ther
, vol.61
, Issue.3
, pp. 275-291
-
-
Sheiner, L.B.1
-
7
-
-
43649098249
-
-
US FDA Center for Drug Evaluation and Research (CDER). Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers [online]. Rockville (MD): US FDA CDER, 2005 Jul 21. Available from URL: http://www.fda.gov/cder/guidance/index. htm#Pharmacology/Toxicology [Accessed 2008 Feb 16]
-
US FDA Center for Drug Evaluation and Research (CDER). Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers [online]. Rockville (MD): US FDA CDER, 2005 Jul 21. Available from URL: http://www.fda.gov/cder/guidance/index. htm#Pharmacology/Toxicology [Accessed 2008 Feb 16]
-
-
-
-
8
-
-
34250658781
-
Getting the dose right: Facts, a blueprint, and encouragements
-
Peck CC, Cross JT. "Getting the dose right": facts, a blueprint, and encouragements. Clin Pharmacol Ther 2007; 82 (1): 12-4
-
(2007)
Clin Pharmacol Ther
, vol.82
, Issue.1
, pp. 12-14
-
-
Peck, C.C.1
Cross, J.T.2
-
10
-
-
43649085628
-
-
Expert Group on Phase One Clinical Trials. Final report [online]. Norwich: The Stationary Office, 2006 Dec 7. Available from URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_063117 [Accessed 2008 Feb 16]
-
Expert Group on Phase One Clinical Trials. Final report [online]. Norwich: The Stationary Office, 2006 Dec 7. Available from URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_063117 [Accessed 2008 Feb 16]
-
-
-
-
11
-
-
0036750745
-
Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999
-
Cross J, Lee H, Westelinck A, et al. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiol Drug Saf 2002; 11 (6): 439-46
-
(2002)
Pharmacoepidemiol Drug Saf
, vol.11
, Issue.6
, pp. 439-446
-
-
Cross, J.1
Lee, H.2
Westelinck, A.3
-
13
-
-
0029564873
-
Tolrestat pharmacokinetic and pharmacodynamic effects on red blood cell sorbitol levels in normal volunteers and in patients with insulin-dependent diabetes
-
van Griensven JM, Jusko WJ, Lemkes HH, et al. Tolrestat pharmacokinetic and pharmacodynamic effects on red blood cell sorbitol levels in normal volunteers and in patients with insulin-dependent diabetes. Clin Pharmacol Ther 1995; 58 (6): 631-40
-
(1995)
Clin Pharmacol Ther
, vol.58
, Issue.6
, pp. 631-640
-
-
van Griensven, J.M.1
Jusko, W.J.2
Lemkes, H.H.3
-
14
-
-
33847659728
-
Effect of an NK1/NK2 receptor antagonist on airway responses and inflammation to allergen in asthma
-
Boot JD, de HS, Tarasevych S, et al. Effect of an NK1/NK2 receptor antagonist on airway responses and inflammation to allergen in asthma. Am J Respir Crit Care Med 2007; 175 (5): 450-7
-
(2007)
Am J Respir Crit Care Med
, vol.175
, Issue.5
, pp. 450-457
-
-
Boot1
JD, D.H.2
Tarasevych, S.3
-
15
-
-
33745019364
-
Evaluation of a vaporizing device (Volcano) for the pulmonary administration of tetrahydrocannabinol
-
Hazekamp A, Ruhaak R, Zuurman L, et al. Evaluation of a vaporizing device (Volcano) for the pulmonary administration of tetrahydrocannabinol. J Pharm Sci 2006; 95 (6): 1308-17
-
(2006)
J Pharm Sci
, vol.95
, Issue.6
, pp. 1308-1317
-
-
Hazekamp, A.1
Ruhaak, R.2
Zuurman, L.3
-
16
-
-
18244370235
-
Biomarkers for the effects of selective serotonin reuptake inhibitors (SSRIs) in healthy subjects
-
Dumont GJ, de Visser SJ, Cohen AF, et al. Biomarkers for the effects of selective serotonin reuptake inhibitors (SSRIs) in healthy subjects. Br J Clin Pharmacol 2005; 59 (5): 495-510
-
(2005)
Br J Clin Pharmacol
, vol.59
, Issue.5
, pp. 495-510
-
-
Dumont, G.J.1
de Visser, S.J.2
Cohen, A.F.3
-
17
-
-
0037238673
-
Biomarkers for the effects of benzodiazepines in healthy volunteers
-
de Visser SJ, van der Post JP, de Waal PP, et al. Biomarkers for the effects of benzodiazepines in healthy volunteers. Br J Clin Pharmacol 2003; 55 (1): 39-50
-
(2003)
Br J Clin Pharmacol
, vol.55
, Issue.1
, pp. 39-50
-
-
de Visser, S.J.1
van der Post, J.P.2
de Waal, P.P.3
-
18
-
-
0035101130
-
Biomarkers for the effects of antipsychotic drugs in healthy volunteers
-
de Visser SJ, van der PJ, Pieters MS, et al. Biomarkers for the effects of antipsychotic drugs in healthy volunteers. Br J Clin Pharmacol 2001; 51 (2): 119-32
-
(2001)
Br J Clin Pharmacol
, vol.51
, Issue.2
, pp. 119-132
-
-
de Visser1
SJ, V.D.P.2
Pieters, M.S.3
-
19
-
-
0037662819
-
REM sleep effects as a biomarker for the effects of antidepressants in healthy volunteers
-
Rijnbeek B, de Visser SJ, Franson KL, et al. REM sleep effects as a biomarker for the effects of antidepressants in healthy volunteers. J Psychopharmacol 2003; 17 (2): 196-203
-
(2003)
J Psychopharmacol
, vol.17
, Issue.2
, pp. 196-203
-
-
Rijnbeek, B.1
de Visser, S.J.2
Franson, K.L.3
-
20
-
-
2442431705
-
No evidence of the usefulness of eye blinking as a marker for central dopaminergic activity
-
van der PJ, de Waal PP, de Kam ML, et al. No evidence of the usefulness of eye blinking as a marker for central dopaminergic activity. J Psychopharmacol 2004; 18 (1): 109-14
-
(2004)
J Psychopharmacol
, vol.18
, Issue.1
, pp. 109-114
-
-
van der, P.J.1
de Waal, P.P.2
de Kam, M.L.3
-
21
-
-
0036905363
-
Evaluation of tests of central nervous system performance after hypoxemia for a model for cognitive impairment
-
van der PJ, Noordzij LA, de Kam ML, et al. Evaluation of tests of central nervous system performance after hypoxemia for a model for cognitive impairment. J Psychopharmacol 2002; 16 (4): 337-43
-
(2002)
J Psychopharmacol
, vol.16
, Issue.4
, pp. 337-343
-
-
van der, P.J.1
Noordzij, L.A.2
de Kam, M.L.3
-
22
-
-
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 (7425): 1222-5
-
(2003)
BMJ
, vol.327
, Issue.7425
, pp. 1222-1225
-
-
Aronson, J.K.1
Ferner, R.E.2
-
23
-
-
0036799756
-
Concentration-effect relationships of two rilmenidine single-dose infusion rates in hypertensive patients
-
de Visser SJ, van der Post JP, Nanhekhan L, et al. Concentration-effect relationships of two rilmenidine single-dose infusion rates in hypertensive patients. Clin Pharmacol Ther 2002; 72 (4): 419-28
-
(2002)
Clin Pharmacol Ther
, vol.72
, Issue.4
, pp. 419-428
-
-
de Visser, S.J.1
van der Post, J.P.2
Nanhekhan, L.3
-
24
-
-
3242717667
-
Pharmacokinetic/ pharmacodynamic assessment of tolerance to central nervous system effects of a 3mg sustained release tablet of rilmenidine in hypertensive patients
-
van der Post JP, de Visser SJ, Schoemaker RC, et al. Pharmacokinetic/ pharmacodynamic assessment of tolerance to central nervous system effects of a 3mg sustained release tablet of rilmenidine in hypertensive patients. J Psychopharmacol 2004; 18 (2): 221-7
-
(2004)
J Psychopharmacol
, vol.18
, Issue.2
, pp. 221-227
-
-
van der Post, J.P.1
de Visser, S.J.2
Schoemaker, R.C.3
-
25
-
-
0035037328
-
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
-
Lesko LJ, Atkinson Jr AJ. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 2001; 41: 347-66
-
(2001)
Annu Rev Pharmacol Toxicol
, vol.41
, pp. 347-366
-
-
Lesko, L.J.1
Atkinson Jr, A.J.2
-
26
-
-
0037384066
-
-
Rolan P, Atkinson Jr AJ, Lesko LJ. Use of biomarkers from drug discovery through clinical practice: report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development. Clin Pharmacol Ther 2003; 73 (4): 284-91
-
Rolan P, Atkinson Jr AJ, Lesko LJ. Use of biomarkers from drug discovery through clinical practice: report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development. Clin Pharmacol Ther 2003; 73 (4): 284-91
-
-
-
-
28
-
-
0032445673
-
Pharmacodynamics and pharmacokinetics of a single oral dose of nitrazepam in healthy volunteers: An interethnic comparative study between Japanese and European volunteers
-
van Gerven JM, Uchida E, Uchida N, et al. Pharmacodynamics and pharmacokinetics of a single oral dose of nitrazepam in healthy volunteers: an interethnic comparative study between Japanese and European volunteers. J Clin Pharmacol 1998; 38 (12): 1129-36
-
(1998)
J Clin Pharmacol
, vol.38
, Issue.12
, pp. 1129-1136
-
-
van Gerven, J.M.1
Uchida, E.2
Uchida, N.3
-
29
-
-
31344453249
-
Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men
-
Wernevik LC, Nystrom P, Johnsson G, et al. Pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor ximelagatran in young healthy Japanese men. Clin Pharmacokinet 2006; 45 (1): 77-84
-
(2006)
Clin Pharmacokinet
, vol.45
, Issue.1
, pp. 77-84
-
-
Wernevik, L.C.1
Nystrom, P.2
Johnsson, G.3
-
30
-
-
1542755161
-
Pharmacokinetic differences between Caucasian and Japanese subjects after single and multiple doses of a potential combined oral contraceptive (Org 30659 and EE)
-
de Visser SJ, Uchida N, van Vliet-Daskalopoulou E, et al. Pharmacokinetic differences between Caucasian and Japanese subjects after single and multiple doses of a potential combined oral contraceptive (Org 30659 and EE). Contraception 2003; 68 (3): 195-202
-
(2003)
Contraception
, vol.68
, Issue.3
, pp. 195-202
-
-
de Visser, S.J.1
Uchida, N.2
van Vliet-Daskalopoulou, E.3
-
31
-
-
43649088212
-
-
European Medicines Agency (EMEA). Note for guidance on statistical principles for clinical trials [document reference CPMP/ICH/363/96; online]. London: EMEA, 1998 Sep. Available from URL: http://www.emea.europa.eu/pdfs/ human/ich/036396en.pdf [Accessed 2008 Feb 16]
-
European Medicines Agency (EMEA). Note for guidance on statistical principles for clinical trials [document reference CPMP/ICH/363/96; online]. London: EMEA, 1998 Sep. Available from URL: http://www.emea.europa.eu/pdfs/ human/ich/036396en.pdf [Accessed 2008 Feb 16]
-
-
-
-
32
-
-
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, et al. 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 (5): 477-86
-
(1997)
Br J Clin Pharmacol
, vol.44
, Issue.5
, pp. 477-486
-
-
Dingemanse, J.1
van Gerven, J.M.2
Schoemaker, R.C.3
-
33
-
-
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 JMA, Roncari G, Schoemaker RC, et al. 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 (5): 487-93
-
(1997)
Br J Clin Pharmacol
, vol.44
, Issue.5
, pp. 487-493
-
-
Van Gerven, J.M.A.1
Roncari, G.2
Schoemaker, R.C.3
-
34
-
-
43649096152
-
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins [document reference CHMP/EWP/89249/2004; online]. London: EMEA, 2007 Jan 24. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/ 8924904enfin.pdf [Accessed 2008 Feb 16]
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins [document reference CHMP/EWP/89249/2004; online]. London: EMEA, 2007 Jan 24. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/ 8924904enfin.pdf [Accessed 2008 Feb 16]
-
-
-
-
35
-
-
43649090448
-
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products [document reference CPMP/EWP/2655/99; online]. London: EMEA, 2000 Jul 27. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/265599en.pdf [Accessed 2008 Feb 16]
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products [document reference CPMP/EWP/2655/99; online]. London: EMEA, 2000 Jul 27. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/265599en.pdf [Accessed 2008 Feb 16]
-
-
-
-
36
-
-
43649094279
-
-
Franson KL, Burggraaf J, Bouman-Trio EA, et al. A phase I, single and fractionated, ascending dose study evaluating the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of an erythropoietic mimetic antibody fusion protein, CNTO528, in healthy male subjects [abstract no. 4283; online]. Blood (ASH Annual Meeting Abstracts) 2005; 106 (11). Available from URL: http://abstracts.hematologylibrary.org/cgi/search?fulltext=franson&sendit= Enter&106&issue=11&journalcode=ashmtg [Accessed 2008 May 13]
-
Franson KL, Burggraaf J, Bouman-Trio EA, et al. A phase I, single and fractionated, ascending dose study evaluating the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of an erythropoietic mimetic antibody fusion protein, CNTO528, in healthy male subjects [abstract no. 4283; online]. Blood (ASH Annual Meeting Abstracts) 2005; 106 (11). Available from URL: http://abstracts.hematologylibrary.org/cgi/search?fulltext=franson&sendit= Enter&volume=106&issue=11&journalcode=ashmtg [Accessed 2008 May 13]
-
-
-
-
37
-
-
0036895091
-
Radioligand studies: Imaging and quantitative analysis
-
Lammertsma AA. Radioligand studies: imaging and quantitative analysis. Eur Neuropsychopharmacol 2002; 12 (6): 513-6
-
(2002)
Eur Neuropsychopharmacol
, vol.12
, Issue.6
, pp. 513-516
-
-
Lammertsma, A.A.1
-
39
-
-
43649095249
-
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Guideline on requirement for first-in-man clinical trials for potential high-risk medicinal products [document reference EMEA/CHMP/SWP/28367/ 2007; online]. London: EMEA, 2000 Jun 3. Available from URL: http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf [Accessed 2008 Feb 16]
-
European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Guideline on requirement for first-in-man clinical trials for potential high-risk medicinal products [document reference EMEA/CHMP/SWP/28367/ 2007; online]. London: EMEA, 2000 Jun 3. Available from URL: http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf [Accessed 2008 Feb 16]
-
-
-
-
40
-
-
33846573411
-
Impact of pharmacometric reviews on new drug approval and labeling decisions: A survey of 31 new drug applications submitted between 2005 and 2006
-
Bhattaram VA, Bonapace C, Chilukuri DM, et al. Impact of pharmacometric reviews on new drug approval and labeling decisions: a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 2007; 81 (2): 213-21
-
(2007)
Clin Pharmacol Ther
, vol.81
, Issue.2
, pp. 213-221
-
-
Bhattaram, V.A.1
Bonapace, C.2
Chilukuri, D.M.3
-
41
-
-
33646649531
-
-
Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005; 7 (3): E503-12
-
Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005; 7 (3): E503-12
-
-
-
|