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The role of databases in drug postmarketing surveillance.
Pharmacoepidemiol Drug Saf. 2001 Aug-Sep; 10(5):407-10.PD

Abstract

This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we have used for assembling these adverse event reports into a case series and analysing them, as well as techniques for employing drug use databases to construct reporting rates in the evaluation of drug safety issues. Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision-making.

Authors+Show Affiliations

Division of Drug Risk Evaluation II, Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, HFD-440, Rockville, MD 20857, USA. rodrigueze@cder.fda.govNo affiliation info availableNo affiliation info available

Pub Type(s)

Case Reports
Journal Article

Language

eng

PubMed ID

11802586

Citation

Rodriguez, E M., et al. "The Role of Databases in Drug Postmarketing Surveillance." Pharmacoepidemiology and Drug Safety, vol. 10, no. 5, 2001, pp. 407-10.
Rodriguez EM, Staffa JA, Graham DJ. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol Drug Saf. 2001;10(5):407-10.
Rodriguez, E. M., Staffa, J. A., & Graham, D. J. (2001). The role of databases in drug postmarketing surveillance. Pharmacoepidemiology and Drug Safety, 10(5), 407-10.
Rodriguez EM, Staffa JA, Graham DJ. The Role of Databases in Drug Postmarketing Surveillance. Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):407-10. PubMed PMID: 11802586.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The role of databases in drug postmarketing surveillance. AU - Rodriguez,E M, AU - Staffa,J A, AU - Graham,D J, PY - 2002/1/23/pubmed PY - 2002/8/3/medline PY - 2002/1/23/entrez SP - 407 EP - 10 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 10 IS - 5 N2 - This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we have used for assembling these adverse event reports into a case series and analysing them, as well as techniques for employing drug use databases to construct reporting rates in the evaluation of drug safety issues. Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision-making. SN - 1053-8569 UR - https://www.unboundmedicine.com/medline/citation/11802586/The_role_of_databases_in_drug_postmarketing_surveillance_ L2 - https://doi.org/10.1002/pds.615 DB - PRIME DP - Unbound Medicine ER -