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Below is a list of archived literature articles (since start of 2004) on MedDRA that have come to the attention of the MSSO. They are provided below for your own reference.
Bailie, G.R., Clark , J.A., Lane, C.E., and Lane, P.L. Hypersensitivitiy reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 20 : 1443 – 1449, 2005
Brosch, S and Abbinante, F. Using EurdaVigilance for safety reporting. Good Clin Pract J 12 :8, 15 - 18, 2005
van Manen, R. Tuning in to signal detection. Good Clin Pract J 12 :8, 9 - 12, 2005
Toneatti, C., Saidi, Y., Meiffredy, V., Tangre, P., Harel, M., Eliette, V., Dormont, J., and Pierre Alboulker, J. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 2005 Nov 7; [Epub ahead of print]
Chan, K.A. and Hauben, M. Signal detection in pharmacovigilance: empirical evaluation of data mining tools. Pharmacoepidemiology and Drug Safety 2005 14: 597-599
Henegar, C., Bousquet, C., Lillo-LeLouet, A., Degoulet, P. and Jaulent,
M.C. Building an ontology of adverse drug reactions for automated signal
generation in pharmacovigilance. Comput Biol Med. 2005 Sep 23; [Epub ahead
of print]
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 and Alcohol Dependence
2005 80:1 (45-51)
MSSO Response
Schroeder, JR, Schmittner, JP, Epstein, DH, and Preston, KL.
Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender.
Drug and Alcohol Dependence 90:45 - 51, 2005
Thiessard, F., Roux, E., Miremont-Salame, G., Fourrier-Reglat, A., Haramburu, F., Tubert-Bitter, P., and Begaud, B. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf. 2005;28(8):731-40
Bousquet, C., Henegar, C., Louet, AL, Degoulet, P. and Jaulent, MC.
Implementation of automated signal generation in pharmacovigilance using
a knowledge-based approach. Int J Med Inform. 2005 Aug;74(7-8):563-571
Kubler, J., Vonk, R., Beimel, S., Gunselmann, W., Homering, M., Nehrdich, D., Koster, J., Theobald, K., and Voleske, P. Adverse event analysis and MedDRA: Business as usual or challenge? Drug Information Journal 2005 39: 63 - 72
Koo, LC, Clark, JA, Quesenberry, CP, Higenbottam, T, Nyberg, F, Wolf, MK, Steinberg, MH, and Forsythe, BH. National differences in reporting ‘peumonia' and ‘pneumonia interstitial': an analysis of the WHO International Drug Monitoring Database on 15 drugs in nine countries for seven pulmonary conditions. Pharmacoepidemiol Drug Saf 2005, Jan 14 [Epub ahead of print]
Bousquet, C, Lagier, G, Lillo-Le Louet, A, Le Beller, C, Venot, A and
Jaulent, MC. Appraisal of the MedDRA Conceptual Structure for Describing
and Grouping Adverse Drug Reactions. Drug Safety 2005 28 (1): 19 – 34
MSSO Response
Bousquet, C, Lagier, G,
Lillo-Le Louet, A, Le Beller, C,
Venot, A and Jaulent M-C.
Drug Safety 2005:28(1), 19-34.
(PDF)
Fescharek, R, Kübler, J, Elsasser, U, Frank, M, Güthlein,
P. Medical dictionary for regulatory activities (MedDRA): Data retrieval
and presentation. Int J Pharm. Med.2004 18 (5): 259 – 269
Hauben, M. Application of an empiric Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics. Pharmacotherapy 2004 Sep; 24 (9):1122-9
Henegar, C, Bousquet, C, Lillo-Le Louet, A, Degoulet, P, Jaulent, M. A knowledge based approach for automated signal detection in Pharmacovigilance. MedInfo 2004: 626 – 630
Marschner, M. Standardization in the Data Management of Clinical Trials Based on MedDRA. Pharm. Ind. 2004 66 (5a): 619 – 622
Campos-Castello, J and Campos-Soler, S. Neuropsychology and epilepsy. Revista de Neurologia 2004 39 (2): 166-177
Klepper MJ. The Periodic Safety Update Report as a Pharmacovigilance Tool. Drug Safety 2004 27 (8): 569-578
Brown EG. Using MedDRA. Implications for Risk Management. Drug Safety 2004 27 (8): 591-602
Main Literature Articles site
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