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MedDRA Literature Articles
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MedDRA Literature Articles |
MSSO Response |
Alvarez, Y, Hidalgo, A, Maignen, F and Slattery, J. Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data: A Retrospective Evaluation of the Potential for Earlier Signalling. Drug Saf 2010; 33 (6): 475-487 |
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Basaria, S, et.al. Adverse events associated with testosterone administration. NEJM 2010 Jul; 363(2): 109 - 22 |
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Schweizer A, Dejager S, Foley JE, Couturier A, Ligueros-Saylan M, Kothny W. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large Phase III type 2 diabetes population. Diabetes Obes Metab. 2010 Jun;12(6):485-94 |
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McCroskery P, Wallace CA, Lovell DJ, Stryker S, Chernyukhin N, Blosch C, Zack DJ. Summary of worldwide pediatric malignancies reported after exposure to etanercept. Pediatr Rheumatol Online J. 2010 Jun 14;8(1):18. [Epub ahead of print] |
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Feudjo-Tepie, MA, Le Roux, G, Beach, KJ, Bennett, D., and Robinson, NJ. Comorbidities of idiopathic thrombocytopenic purpura: a population-based study. Advances in Hematology 2009, doi:10.1155/2009/963506 |
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Moore, TJ, Cohen, MR, and Furburg, CD. Quarter Watch: 2008 Quarter 1. Hospital Pharmacy 2009, 44(1): 47 - 56 |
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Merril, GH. The MedDRA paradox. AMIA 2008 Symposium Proceedings 2008, 470 - 474 |
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| Hauben, M and Reich, L. Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: a retrospective evaluation. J. Clin. Pharmacol. 2005, 45: 378 - 384 | |
| Pearson, RK et al. Influence of the MedDRA® hierarchy on pharmacovigilance data mining results. Int J Med Inform. 2009 Feb 18. [Epub ahead of print] | |
| 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 | MSSO Response |
| 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 | MSSO Response |
| 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] | MSSO Response |
| 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] | MSSO Response |
| 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 |
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