-
1
-
-
49749105179
-
-
Guidance for industry: premarketing risk assessment, March 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6357fnl.htm [Accessed 2008 Jan 20]
-
Guidance for industry: premarketing risk assessment, March 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6357fnl.htm [Accessed 2008 Jan 20]
-
-
-
-
2
-
-
49749083042
-
-
Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment, March 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6359OCC.htm [Accessed 2008 Jan 20]
-
Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment, March 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6359OCC.htm [Accessed 2008 Jan 20]
-
-
-
-
3
-
-
49749089290
-
-
Guidance for industry: development and use of risk minimization action plans, March 2005 [online]. Available from URL: http://www.fda.gov/cder/ guidance/6358fnl.htm [Accessed 2008 Jan 20]
-
Guidance for industry: development and use of risk minimization action plans, March 2005 [online]. Available from URL: http://www.fda.gov/cder/ guidance/6358fnl.htm [Accessed 2008 Jan 20]
-
-
-
-
4
-
-
49749089662
-
-
Guideline on risk management systems for medicinal products for human use, 14 November 2005 [online]. Available from URL: http://www.emea.europa.eu/ pdfs/human/euleg/9626805en.pdf [Accessed 2008 Jan 20]
-
Guideline on risk management systems for medicinal products for human use, 14 November 2005 [online]. Available from URL: http://www.emea.europa.eu/ pdfs/human/euleg/9626805en.pdf [Accessed 2008 Jan 20]
-
-
-
-
5
-
-
73949085116
-
-
Innovative drug development approaches EMEA/127318/, 22 March, online, Available from URL:, Accessed 2008 Jan 20
-
Innovative drug development approaches (EMEA/127318/ 2007): final report of the EMEA/CHMP think-tank on innovative drug development, 22 March 2007 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/itf/ 12731807en.pdf [Accessed 2008 Jan 20]
-
(2007)
final report of the EMEA/CHMP think-tank on innovative drug development
-
-
-
7
-
-
49749133479
-
-
ICH harmonised tripartite guideline: pharmacovigilance planning (E2E), 18 November 2004 [online]. Available from URL: http://www.ich.org/LOB/media/ MEDIA1195.pdf [Accessed 2008 Jan 20]
-
ICH harmonised tripartite guideline: pharmacovigilance planning (E2E), 18 November 2004 [online]. Available from URL: http://www.ich.org/LOB/media/ MEDIA1195.pdf [Accessed 2008 Jan 20]
-
-
-
-
8
-
-
33845599928
-
Risk management planning: Time to deliver
-
Waller P. Risk management planning: time to deliver. Pharmacoepidemiol Drug Saf 2006; 15 (12): 850-1
-
(2006)
Pharmacoepidemiol Drug Saf
, vol.15
, Issue.12
, pp. 850-851
-
-
Waller, P.1
-
9
-
-
33846073027
-
Adverse drug reactions: No farewell to harms
-
Feb;
-
Aronson JK. Adverse drug reactions: no farewell to harms. Br J Clin Pharmacol 2007 Feb; 63 (2): 131-5
-
(2007)
Br J Clin Pharmacol
, vol.63
, Issue.2
, pp. 131-135
-
-
Aronson, J.K.1
-
10
-
-
3042653096
-
Clinical pharmacology: Special safety considerations in drug development and pharmacovigilance
-
Atuah KN, Hughes D, Pirmohamed M. Clinical pharmacology: special safety considerations in drug development and pharmacovigilance. Drug Saf 2004; 27 (8): 535-54
-
(2004)
Drug Saf
, vol.27
, Issue.8
, pp. 535-554
-
-
Atuah, K.N.1
Hughes, D.2
Pirmohamed, M.3
-
13
-
-
33744528341
-
Pharmacovigilance in a genomic era
-
May;
-
Farahani P, Levine M. Pharmacovigilance in a genomic era. Pharmacogenomics J 2006 May; 6 (3): 158-61
-
(2006)
Pharmacogenomics J
, vol.6
, Issue.3
, pp. 158-161
-
-
Farahani, P.1
Levine, M.2
-
14
-
-
33744972059
-
Ethnic differences in risks of adverse reactions: Biomedical approach is insufficient to explain ethnic differences
-
Jun 10;
-
Mhlongo SW, Mbokazi AJ. Ethnic differences in risks of adverse reactions: biomedical approach is insufficient to explain ethnic differences. BMJ 2006 Jun 10; 332 (7554): 1393
-
(2006)
BMJ
, vol.332
, Issue.7554
, pp. 1393
-
-
Mhlongo, S.W.1
Mbokazi, A.J.2
-
15
-
-
33646595301
-
Strategies in the management of alemtuzumab-related side effects
-
Apr;
-
Osterborg A, Karlsson C, Lundin J, et al. Strategies in the management of alemtuzumab-related side effects. Semin Oncol 2006 Apr; 33 (2 Suppl. 5): S29-35
-
(2006)
Semin Oncol
, vol.33
, Issue.2 SUPPL. 5
-
-
Osterborg, A.1
Karlsson, C.2
Lundin, J.3
-
18
-
-
49749103918
-
Statistical analysis of safety data in clinical trials: Management of safety information from clinical trials
-
Geneva: CIOMS, 131-64
-
Statistical analysis of safety data in clinical trials: management of safety information from clinical trials. Report of CIOMS Working Group VI. Geneva: CIOMS, 2005: 131-64
-
(2005)
Report of CIOMS Working Group VI
-
-
-
19
-
-
26444585526
-
The quality of information on monitoring for haematological adverse drug reactions
-
Oct;
-
Ferner RE, Coleman J, Pirmohamed M, et al. The quality of information on monitoring for haematological adverse drug reactions. Br J Clin Pharmacol 2005 Oct; 60 (4): 448-51
-
(2005)
Br J Clin Pharmacol
, vol.60
, Issue.4
, pp. 448-451
-
-
Ferner, R.E.1
Coleman, J.2
Pirmohamed, M.3
-
20
-
-
33745774356
-
Thinking outside the (black) box: A new research agenda
-
Jun;
-
Seligman PJ. Thinking outside the (black) box: a new research agenda. Pharmacoepidemiol Drug Saf 2006 Jun; 15 (6): 387-9
-
(2006)
Pharmacoepidemiol Drug Saf
, vol.15
, Issue.6
, pp. 387-389
-
-
Seligman, P.J.1
-
21
-
-
33746196538
-
Communicating information about drug safety
-
Jul 15;
-
Ferner RE, Aronson JK. Communicating information about drug safety. BMJ 2006 Jul 15; 333 (7559): 143-5
-
(2006)
BMJ
, vol.333
, Issue.7559
, pp. 143-145
-
-
Ferner, R.E.1
Aronson, J.K.2
-
22
-
-
0037275431
-
A model for the future conduct of pharmacovigilance
-
Jan;
-
Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003 Jan; 12 (1): 17-29
-
(2003)
Pharmacoepidemiol Drug Saf
, vol.12
, Issue.1
, pp. 17-29
-
-
Waller, P.C.1
Evans, S.J.2
-
23
-
-
33646246187
-
A prescription for better prescribing
-
May;
-
Aronson JK. A prescription for better prescribing. Br J Clin Pharmacol 2006 May; 61 (5): 487-91
-
(2006)
Br J Clin Pharmacol
, vol.61
, Issue.5
, pp. 487-491
-
-
Aronson, J.K.1
-
24
-
-
22244488721
-
Drug utilization statistics for individual-level pharmacy dispensing data
-
Jul;
-
Hallas J. Drug utilization statistics for individual-level pharmacy dispensing data. Pharmacoepidemiol Drug Saf 2005 Jul; 14 (7): 455-63
-
(2005)
Pharmacoepidemiol Drug Saf
, vol.14
, Issue.7
, pp. 455-463
-
-
Hallas, J.1
-
25
-
-
33846078041
-
Isotretinoin, pregnancies, abortions and birth defects: A population-based perspective
-
Feb;
-
Berard A, Azoulay L, Koren G, et al. Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective. Br J Clin Pharmacol 2007 Feb; 63 (2): 196-205
-
(2007)
Br J Clin Pharmacol
, vol.63
, Issue.2
, pp. 196-205
-
-
Berard, A.1
Azoulay, L.2
Koren, G.3
-
26
-
-
33846969181
-
Potential risk of progressive multifocal leukoencephalopathy with natalizumab therapy: Possible interventions
-
Feb;
-
Stuve O, Marra CM, Cravens PD, et al. Potential risk of progressive multifocal leukoencephalopathy with natalizumab therapy: possible interventions. Arch Neurol 2007 Feb; 64 (2): 169-76
-
(2007)
Arch Neurol
, vol.64
, Issue.2
, pp. 169-176
-
-
Stuve, O.1
Marra, C.M.2
Cravens, P.D.3
-
27
-
-
34249079172
-
A framework for the delivery of public health: An ecological approach
-
Jun;
-
Nurse J, Edmondson-Jones P. A framework for the delivery of public health: an ecological approach. J Epidemiol Community Health 2007 Jun; 61 (6): 555-8
-
(2007)
J Epidemiol Community Health
, vol.61
, Issue.6
, pp. 555-558
-
-
Nurse, J.1
Edmondson-Jones, P.2
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