Below is a list of 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. The most recently added articles are in blue.
On a monthly basis, the MSSO reviews literature from several
scientific literature databases concerning MedDRA. The MSSO drafts and
posts a commentary or response to certain articles as needed.
Lindquist, M. VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal 2008; 42: 409 - 419
Czarnecki, A and Voss, S. Safety Signals Using proportional reporting ratios from company and regulatory authority databases. Drug Information Journal 2008; 42: 205–210
Richesson RL, Fung KW, Krischer JP. Heterogeneous but "standard" coding systems for adverse events: Issues in achieving interoperability between apples and oranges. Contemp Clin Trials. 2008 Mar 5 [Epub ahead of print]
DuMouchel, W, Fram, D, Yang, X, Mahmoud, RA, Grogg , AL , Engelhart, L, and Ramaswamy, K. Antipsychotics, glycemic disorders and life-threatening diabetic events: a Bayesian data mining analysis of the FDA Adverse Event Reporting System (1968 - 2004). Annals of Clinical Psychiatry 2008; 20(1): 21 – 31
Hochberg, AM, Reisinger, SJ, Pearson, RK, O'Hara, DJ, and Hall, K. Using data mining to predict safety actions from FDA Adverse Event Reporting System data. Drug Information Journal 2007; 41(5): 633 - 642
Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. Journal of Clinical Oncology, 2007 Nov 10;25(32):5121-7
Alecu, I, Bousquet, C, Degoulet, P, and Jaulent, M-C. PharmARTS: Terminology Web Services for Drug Safety Coding and Retrieval. MEDINFO 2007, 699 – 704
Journot, V, Tabuteau, S, Collin, F, Molina, J-M,
Chene, G, and Rancinan, C; the ALIZE Study Group. About the necessity
to manage events coded with MedDRA prior to statistical analysis:
Proposal of a strategy with application to a randomized clinical
trial, ANRS 099 ALIZE. Contemporary Clinical Trials 2007 Jun 7;
[Epub ahead of print]
Mozzicato, P. Standardised MedDRA Queries: Their Role
in Signal Detection. Drug Safety 2007, 30(7): 617-619
Bo, QY, Xiong, NN, Zou, JD, Jiang, M, liu, F, and Zhao-Wong, A. Internationally agreed medical terminology: Medical Dictionary for Regulatory Activities. Chin J Clin Pharmacol Ther 2007 May; 12(5).
Woodworth T, Furst DE, Alten R, Bingham C, Yocum D,
Sloan V, Tsuji W, Stevens R, Fries J, Witter J, Johnson K, Lassere M,
Brooks P. Standardizing assessment and reporting of adverse effects in
rheumatology clinical trials II: the Rheumatology Common Toxicity
Criteria v.2.0. J Rheumatol. 2007 Jun;34(6):1401-14.
Hansen, RA, Gartlehner, G, Powell, GE, and Sadnler, RS. Serious adverse events with Infliximab: analysis of spontaneously reported adverse events. Clin Gastroenterol Hepatol 2007, May 2 [Epub ahead of print]
Mozzicato, P. MedDRA - Past and Future. RAJ Pharma 2006 17(12): 797 - 805
Starzyk, K., Richards, S., Yee, J., Smith, S.E., and Kingma, W. The long-term international safety experience of imiglucerase therapy for Gaucher disease. Mol Genet Metab 2006 Oct 30; [Epub ahead of print]
Alecu, I. , Bousquet, C., Mougin, F., and Jaulent, M-C. Mapping of the WHO-ART terminology on SNOMED CT to improve grouping of related adverse drug reactions. Stud Health Technol Inform 124: 833 - 838, 2006
Harrison, J. and Zhao-Wong, A. Working with MedDRA to improve data standards. Good Clin Pract J 13(9): 25 - 28, 2006
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 Information Journal 2006 40 : 291-303
Literature Article Archive
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