Results 261 to 270 of about 25,779 (305)
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Postmarketing surveillance of food additives
Regulatory Toxicology and Pharmacology, 1994Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the ...
Harriett H. Butchko +2 more
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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
Jeffrey L. Carson +3 more
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Postmarketing Safety Surveillance
Pharmaceutical Medicine, 2010Management of spontaneous reports remains one of the most important activities in postmarketing surveillance. Increasingly, spontaneous reporting data are publically available, particularly following the criticism from the European Ombudsman over data secrecy by the European Medicines Agency in August this year. New legislation in the EU could mean the
Brian Edwards, Upasana Prabhakar
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Postmarketing surveillance for drug abuse
Drug and Alcohol Dependence, 2003Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested.
Theodore J. Cicero, Cynthia L. Arfken
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Dabigatran and Postmarketing Reports of Bleeding
New England Journal of Medicine, 2013Serious and fatal bleeding events associated with use of the anticoagulant dabigatran have been reported. The FDA used the Mini-Sentinel database to determine that the actual rates of bleeding events were not higher with dabigatran than with warfarin.
Mary Ross Southworth +2 more
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Postmarketing Surveillance Methodologies
Drug Intelligence & Clinical Pharmacy, 1988This article describes and discusses the strengths and limitations of the major pharmacoepidemiologic methodologies employed in postmarketing drug surveillance and describes the current status of the U.S. surveillance system. The main methodologies employed in postmarketing drug surveillance include controlled clinical trials, observational ...
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Postmarketing Experience with Topiramate and Cognition
Epilepsia, 2001Summary: Ideal antiepileptic drugs (AEDs) are designed to stop seizures with limited central nervous system (CNS) side effects. However, CNS‐related treatment‐emergent adverse events (TEAEs) often occur in patients receiving AEDs. Topiramate (TPM) is an AED proven to be safe and effective as adjunctive treatment for epilepsy patients with partial ...
Andres M. Kanner +8 more
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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.
J. C. Cerrito, P. B. 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
Stephen G. Bryant +2 more
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Ibrutinib's Cardiotoxicity-An Opportunity for Postmarketing Regulation.
JAMA Oncology, 2020Ibrutinib is an irreversible inhibitor of Bruton tyrosine kinase (BTK) that is indicated for multiple hematological malignancies, including previously untreated chronic lymphocytic leukemia (CLL).
M. Ratain, J. Moslehi, A. Lichter
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