-
1
-
-
0003177157
-
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
European Parliament, European Council. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Communities L 121 (2001) 34-44
-
(2001)
Off J Eur Communities
, vol.L 121
, pp. 34-44
-
-
European Parliament, European Council,1
-
3
-
-
0032991290
-
The Medical Dictionary for Regulatory Activities (MedDRA)
-
Brown E.G., Wood L., and Wood S. The Medical Dictionary for Regulatory Activities (MedDRA). Drug Saf 20 2 (1999) 109-117
-
(1999)
Drug Saf
, vol.20
, Issue.2
, pp. 109-117
-
-
Brown, E.G.1
Wood, L.2
Wood, S.3
-
4
-
-
39149127791
-
-
ICH Points to consider Working Group. MedDRA® term selection: points to consider. ICH-endorsed guide for MedDRA users: application to adverse drug reactions/adverse events & medical and social history & indications. Release 3.6, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.
-
ICH Points to consider Working Group. MedDRA® term selection: points to consider. ICH-endorsed guide for MedDRA users: application to adverse drug reactions/adverse events & medical and social history & indications. Release 3.6, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.
-
-
-
-
5
-
-
39149083595
-
-
ICH Points to consider Working Group. MedDRA® data retrieval and presentation: points to consider. ICH-endorsed guide for MedDRA users on data output. Release 1.1, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.
-
ICH Points to consider Working Group. MedDRA® data retrieval and presentation: points to consider. ICH-endorsed guide for MedDRA users on data output. Release 1.1, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.
-
-
-
-
6
-
-
3042542441
-
Standardization in the data management of clinical trials based on MedDRA
-
Marschner M. Standardization in the data management of clinical trials based on MedDRA. Pharm Ind 66 5a (2004) 619-622
-
(2004)
Pharm Ind
, vol.66
, Issue.5 a
, pp. 619-622
-
-
Marschner, M.1
-
7
-
-
28744451248
-
Experience using MedDRA for global events coding in HIV clinical trials
-
Tonéatti C., Saïdi Y., Meiffrédy V., et al. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 27 (2006) 13-22
-
(2006)
Contemp Clin Trials
, vol.27
, pp. 13-22
-
-
Tonéatti, C.1
Saïdi, Y.2
Meiffrédy, V.3
-
8
-
-
0036300273
-
Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART
-
Brown E.G. Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Drug Saf 25 6 (2002) 445-452
-
(2002)
Drug Saf
, vol.25
, Issue.6
, pp. 445-452
-
-
Brown, E.G.1
-
9
-
-
3042609851
-
Using MedDRA: implications for risk management
-
Brown E.G. Using MedDRA: implications for risk management. Drug Saf 27 8 (2004) 591-602
-
(2004)
Drug Saf
, vol.27
, Issue.8
, pp. 591-602
-
-
Brown, E.G.1
-
10
-
-
22544439665
-
Implementation of automated signal generation in pharmacovigilance using a knowledge-based approach
-
Bousquet C., Hénégar C., Lillo-Le Louët A., Degoulet P., and Jaulenta M.C. Implementation of automated signal generation in pharmacovigilance using a knowledge-based approach. Int J Med Inform 74 (2005) 563-571
-
(2005)
Int J Med Inform
, vol.74
, pp. 563-571
-
-
Bousquet, C.1
Hénégar, C.2
Lillo-Le Louët, A.3
Degoulet, P.4
Jaulenta, M.C.5
-
11
-
-
33646829762
-
Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance
-
Hénégar C., Bousquet C., Lillo-Le Louët A., Degoulet P., and Jaulent M.C. Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance. Comput Biol Med 36 7-8 (2006) 748-767
-
(2006)
Comput Biol Med
, vol.36
, Issue.7-8
, pp. 748-767
-
-
Hénégar, C.1
Bousquet, C.2
Lillo-Le Louët, A.3
Degoulet, P.4
Jaulent, M.C.5
-
12
-
-
23644450583
-
Trends in spontaneous adverse drug reaction reports to the French Pharmacovigilance System (1986-2001)
-
Thiessard F., Roux E., Miremont-Salamé G., et al. Trends in spontaneous adverse drug reaction reports to the French Pharmacovigilance System (1986-2001). Drug Saf 28 8 (2005) 731-740
-
(2005)
Drug Saf
, vol.28
, Issue.8
, pp. 731-740
-
-
Thiessard, F.1
Roux, E.2
Miremont-Salamé, G.3
-
13
-
-
24644436754
-
Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender
-
Schroeder J.R., Schmittner J.P., Epstein D.H., and Preston K.L. Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender. Drug Alcohol Depend 80 1 (2005) 45-51
-
(2005)
Drug Alcohol Depend
, vol.80
, Issue.1
, pp. 45-51
-
-
Schroeder, J.R.1
Schmittner, J.P.2
Epstein, D.H.3
Preston, K.L.4
-
14
-
-
0036191693
-
Which coding system for therapeutic information in evidence-based medicine
-
Strang N., Cucherat M., and Boissel J.P. Which coding system for therapeutic information in evidence-based medicine. Comput Methods Programs Biomed 68 (2002) 73-85
-
(2002)
Comput Methods Programs Biomed
, vol.68
, pp. 73-85
-
-
Strang, N.1
Cucherat, M.2
Boissel, J.P.3
-
15
-
-
3042513494
-
The periodic safety update report as a pharmacovigilance tool
-
Klepper M.J. The periodic safety update report as a pharmacovigilance tool. Drug Saf 27 8 (2004) 569-578
-
(2004)
Drug Saf
, vol.27
, Issue.8
, pp. 569-578
-
-
Klepper, M.J.1
-
16
-
-
20044391202
-
Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial
-
Molina J.M., Journot V., Morand-Joubert L., et al. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis 191 (2005) 830-839
-
(2005)
J Infect Dis
, vol.191
, pp. 830-839
-
-
Molina, J.M.1
Journot, V.2
Morand-Joubert, L.3
-
17
-
-
0032493043
-
A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors
-
Carr A., Samaras K., Burton S., et al. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS 12 7 (1998) F51-F58
-
(1998)
AIDS
, vol.12
, Issue.7
-
-
Carr, A.1
Samaras, K.2
Burton, S.3
-
18
-
-
0345064200
-
Combination antiretroviral therapy and the risk of myocardial infarction
-
The Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
-
The Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med 349 21 (2003) 1993-2003
-
(2003)
N Engl J Med
, vol.349
, Issue.21
, pp. 1993-2003
-
-
-
19
-
-
33744809516
-
Use of efavirenz is not associated with a higher risk of depressive disorders: a substudy of the randomized clinical trial ALIZE-ANRS 099
-
Journot V., Chêne G., De Castro N., et al. Use of efavirenz is not associated with a higher risk of depressive disorders: a substudy of the randomized clinical trial ALIZE-ANRS 099. Clin Infect Dis 42 12 (2006) 1790-1799
-
(2006)
Clin Infect Dis
, vol.42
, Issue.12
, pp. 1790-1799
-
-
Journot, V.1
Chêne, G.2
De Castro, N.3
-
20
-
-
0037218258
-
Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA)
-
[erratum appears in Drug Saf 2004;27(1):61]
-
Brown E.G. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA). [erratum appears in Drug Saf 2004;27(1):61]. Drug Saf 26 3 (2003) 145-158
-
(2003)
Drug Saf
, vol.26
, Issue.3
, pp. 145-158
-
-
Brown, E.G.1
-
21
-
-
12544259120
-
Appraisal of the MedDRA conceptual structure for describing and grouping adverse drug reactions
-
Bousquet C., Lagier G., Lillo-Le Louët A., et al. Appraisal of the MedDRA conceptual structure for describing and grouping adverse drug reactions. Drug Saf 28 1 (2005) 19-34
-
(2005)
Drug Saf
, vol.28
, Issue.1
, pp. 19-34
-
-
Bousquet, C.1
Lagier, G.2
Lillo-Le Louët, A.3
-
22
-
-
13844294109
-
Adverse event analysis and MedDRA: Business as usual or challenge?
-
Kübler J., Vonk R., Beimel S., et al. Adverse event analysis and MedDRA: Business as usual or challenge?. Drug Inf J 39 (2005) 63-72
-
(2005)
Drug Inf J
, vol.39
, pp. 63-72
-
-
Kübler, J.1
Vonk, R.2
Beimel, S.3
-
23
-
-
33747585862
-
Proposed terminology changes to facilitate the analysis of MedDRA®-coded data
-
Zhao-Wong A.C., Rump E., Moraleda T., Mozzicato P., and Revelle P. Proposed terminology changes to facilitate the analysis of MedDRA®-coded data. Drug Inf J 40 (2006) 291-303
-
(2006)
Drug Inf J
, vol.40
, pp. 291-303
-
-
Zhao-Wong, A.C.1
Rump, E.2
Moraleda, T.3
Mozzicato, P.4
Revelle, P.5
-
24
-
-
39149133499
-
-
CIOMS Working Group for SMQs. List of SMQ topics for development by CIOMS Working Group for SMQs (as of 28 Feb 2007). MSSO: Standardized MedDRA Queries (SMQs). 2007. [http://www.meddramsso.com/MSSOWeb/SMQ/smqlist.htm]. Accessed 24 May, 2007.
-
CIOMS Working Group for SMQs. List of SMQ topics for development by CIOMS Working Group for SMQs (as of 28 Feb 2007). MSSO: Standardized MedDRA Queries (SMQs). 2007. [http://www.meddramsso.com/MSSOWeb/SMQ/smqlist.htm]. Accessed 24 May, 2007.
-
-
-
|