Results 211 to 220 of about 12,493 (244)
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Techniques of Postmarketing Surveillance
Medical Toxicology, 1986While there are many systems available for postmarketing surveillance today, none is ideal for every situation. Recent progress has been made through computerised data bases which allows for rapid identification of patients with diseases or drugs of interest. Careful planning, with attention to the relative strengths and weaknesses of each, will permit
J L, Carson, B L, Strom
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Assessing risk in postmarketing surveillance
Journal of Biopharmaceutical Statistics, 1991We need to find some way to assess the probability of risk for individuals taking medications for a prolonged period of time either singly or, as is usually more likely, in combinations. It is not possible to perform detailed, controlled studies for all combinations of drugs, not even those most commonly administered.
P B, Cerrito, J C, Cerrito
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New approaches to postmarketing surveillance
Psychopharmacology, 1986As part of a large-scale ongoing project exploring new pharmacy-based methods of postmarketing surveillance, we are comparing a patient-initiated monitoring system to a staff-initiated approach. Here we report data only from staff-initiated, computer-directed telephone interviews with 231 outpatients approximately 2 weeks after they had been prescribed
S, Fisher, S G, Bryant, R M, Kluge
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A Postmarket Surveillance Benchmarking Exercise
Biomedical Instrumentation & Technology, 2014Monitoring device performance after a product has been launched is a critical aspect of maintaining product safety. Not only is it the right thing to do, but our regulators expect that it’s done. • FDA 21 CFR 822 discusses monitoring and evaluation of product performance data.
Pat, Baird, Andrea, Schwartz
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Postmarketing Surveillance for Oncology Drugs
Clinical Journal of Oncology Nursing, 2008Adverse effects of cancer therapies may occur more than three decades after drug administration. Continued vigilance in postmarketing use of oncology agents is necessary to accurately track adverse effects, update prescribing information, and alert healthcare providers in a timely manner.
Pamela Hallquist, Viale, Susan, Moore
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Pemoline Hepatotoxicity and Postmarketing Surveillance
Journal of the American Academy of Child & Adolescent Psychiatry, 2001To review the numerous reports of hepatotoxic adverse drug reactions (ADRs) ascribed to pemoline that were sent to the U.S. Food and Drug Administration (FDA) between 1975 and 1996 and to describe the medical community's lack of awareness of these reports.All ADR reports from 1975 through 1996 wherein pemoline was the suspect agent were obtained from ...
D J, Safer, J M, Zito, J E, Gardner
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Cefmetazole postmarketing surveillance in Japan
Journal of Antimicrobial Chemotherapy, 1989The Sankyo Company Ltd had conducted a postmarketing surveillance programme on cefmetazole sodium since its marketing introduction in Japan. Two data collection approaches were used: a survey in which participating physicians provided complete information on all their patients who received cefmetazole for treatment of infection, and two voluntary ...
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The Canadian journal of hospital pharmacy, 1987
Postmarketing surveillance (PMS) studies allow for the systematic and comprehensive monitoring of the beneficial and harmful effects of prescription drugs as well as their usage patterns. The objectives of PMS are to assess the uses and effects of new drugs under conditions of customary clinical use.
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Postmarketing surveillance (PMS) studies allow for the systematic and comprehensive monitoring of the beneficial and harmful effects of prescription drugs as well as their usage patterns. The objectives of PMS are to assess the uses and effects of new drugs under conditions of customary clinical use.
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Postmarketing Surveillance (PMS)
1985The term postmarketing surveillance should convey the meaning that the use of a drug after marketing is surveyed both for efficacy and safety; however, as the term is currently used, the emphasis is on safety rather than efficacy. One of the reasons for the lack of emphasis on efficacy has been the fact that the originating pharmaceutical company will ...
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ICD Leads and Postmarketing Surveillance
New England Journal of Medicine, 2012To the Editor: Product quality is our highest priority at St. Jude Medical (SJM). To ensure accuracy and address misperceptions, we are providing responses to assertions in the Perspective article by Hauser in this issue of the Journal.1 Assertion: Recommendations for following patients with Riata silicone-only leads for implantable cardioverter ...
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