MedDRA

Introductory guide, MedDRA version 12.0, March 2009 [online]. Available to MedDRAsubscribers from URL: http://www.meddramsso.com/translations/translationdownloads.htm [Accessed 2009 Apr 1]

Mozzicato P. MedDRA — past and future. Regul Aff J Pharma 2006; 17 (12): 797–805

Wood KL. TheMedical Dictionary for Drug Regulatory Affairs (MEDDRA) project. Pharmacoepidemiol Drug Saf 1994; 3: 7–13

Brown EG, Wood KL, Wood SM. The Medical Dictionary for Regulatory Activities (MedDRA). Drug Saf 1999; 20 (2): 109–17

Cone M. Regulatory update: the long-awaited MedDRA has arrived! Good Clin Pract J 1999; 6 (1): 42–3

Huntley K, Veverka MJ, Golden M. The FDA’s medical dictionary for drug regulatory affairs alpha test. Drug Inf J 1995; 29 (4): 1133–43

MedDRA term selection: points to consider, release 3.12, 1 April 2009 [online]. Available from URL: http://www.meddramsso.com/MSSOWeb/document_library/9491-1200_TermSelPTC_R312_mar2009.pdf [Accessed 2009 Apr 1]

MedDRA data retrieval and presentation: points to consider, release 2.0, 1 April 2009 [online]. Available from URL: http://www.meddramsso.com/MSSOWeb/Document_Library/9610-1200_DatRetPTC_R20_mar2009.pdf [Accessed 2009 Apr 1]

Zhao-Wong A, Rump E, Moraleda T, et al. Proposed terminology changes to facilitate the analysis of MedDRA-coded data. Drug Inf J 2006; 40: 291–303

Brown EG. Effects of coding dictionary on signal generation: a consideration of the use of MedDRA compared with WHO-ART. Drug Saf 2002; 25 (6): 445–52

Brown EG. Using MedDRA: implications for risk management. Drug Saf 2004; 27 (8): 591–602

Fescharek R, Kübler J, Elsasser U, et al. Medical Dictionary for Regulatory Activities: data retrieval and presentation. Int J Pharm Med 2004; 18 (5): 259–69

Tonéatti C, Saïdi Y, Meiffrédy V, et al. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 2006; 27: 13–22

Tremmel LT, Scarpone L. Using MedDRA for adverse events in cancer trials: experience, caveats, and advice. Drug Inf J 2001; 35: 845–52

Brown EG, Douglas S. Tabulation and analysis of pharmacovigilance data using the Medical Dictionary for Regulatory Activities. Pharmacoepidemiol Drug Saf 2000; 9: 479–89

Introductory guide for Standardised MedDRA Queries (SMQs) version 12.0, March 2009 [online]. Available to MedDRA subscribers from URL: http://www.meddramsso.com/translations/translationdownloads.htm [Accessed 2009 Apr 1]

Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J 2008; 42: 409–19