Affiliation: Food and Drug Administration
- Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports databaseAna Szarfman
Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Drug Saf 25:381-92. 2002..The application of these tools may ultimately improve usage recommendations...
- Atypical antipsychotics and pituitary tumors: a pharmacovigilance studyAna Szarfman
Office of Pharmacoepidemiology and Statistical Sciences, Immediate Office, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
Pharmacotherapy 26:748-58. 2006..To analyze the disproportionality of reporting of hyperprolactinemia, galactorrhea, and pituitary tumors with seven widely used antipsychotic drugs...
- An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting systemEric Colman
Division of Metabolism and Endocrinology Products, United States Food and Drug Administration, Silver Spring, MD 20993, USA
Pharmacoepidemiol Drug Saf 17:1068-76. 2008..We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration's (FDA) spontaneous adverse event (AE) reporting system (AERS)...
- Pharmacovigilance in the 21st century: new systematic tools for an old problemAna Szarfman
Pharmacotherapy 24:1099-104. 2004..Validated data mining techniques offer great promise to enhance pharmacovigilance practices...
- Perspectives on the use of data mining in pharmaco-vigilanceJune Almenoff
GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Drug Saf 28:981-1007. 2005..The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues...
- Reply: The evaluation of data mining methods for the simultaneous and systematic detection of safety signals in large databases: lessons to be learnedJonathan G Levine
Br J Clin Pharmacol 61:105-13; author reply 115-7. 2006
- Association between pathologic gambling and parkinsonian therapy as detected in the Food and Drug Administration Adverse Event databaseAna Szarfman
Arch Neurol 63:299-300; author reply 300. 2006