Results 211 to 220 of about 21,353 (254)
A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database. [PDF]
Cancer MedXu Y, Wang D, Xu Y.
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Safety and effectiveness of stiripentol in patients with Dravet syndrome: A prospective, 3-year, postmarketing surveillance study. [PDF]
Dev Med Child NeurolKitamura Y +6 more
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2011
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with ...
Vera, Vlahović-Palčevski +1 more
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Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with ...
Vera, Vlahović-Palčevski +1 more
+5 more sources
International Journal of Pharmaceutical Medicine, 2005
The postmarketing monitoring and evaluation of the safety and effectiveness of all medicines is essential. The patterns of use, effectiveness and safety of a drug in general use may be substantially different to that in clinical trials due to differences in prescribing and patient groups; differences include the limited number of patients in studies ...
Sanath Hegde +2 more
openaire +1 more source
The postmarketing monitoring and evaluation of the safety and effectiveness of all medicines is essential. The patterns of use, effectiveness and safety of a drug in general use may be substantially different to that in clinical trials due to differences in prescribing and patient groups; differences include the limited number of patients in studies ...
Sanath Hegde +2 more
openaire +1 more source
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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Review of Transporter‐Related Postmarketing Requirement or Postmarketing Commitment Studies
The Journal of Clinical Pharmacology, 2016AbstractThe objectives of this report are to summarize the content and status of transporter‐related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results
Ying, Fan +3 more
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Famotidine: Postmarketing Clinical Experience
Scandinavian Journal of Gastroenterology, 1987A postmarketing survey of famotidine usage (phase IV survey) tracked 6346 patients at 602 locations from August 1985 to April 1986. Through the survey, the efficacy and the safety of famotidine were studied. The patients included 4618 cases of peptic ulcer, 106 cases of reflux esophagitis, 1006 cases of upper gastrointestinal tract bleeding, 343 cases ...
K, Saigenji, H, Fukutomi, S, Nakazawa
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Postmarketing Drug Surveillance
JAMA: The Journal of the American Medical Association, 1984To the Editor.— We concur with Rossi et al 1 that alert physicians and others spontaneously reporting their suspicions of adverse drug reactions is critical to the discovery of rare effects of marketed drugs. Spontaneous reporting is an essential element of the multicomponent postmarketing surveillance systems established by pharmaceutical ...
E K, Borden +3 more
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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 ...
H H, Butchko, C, Tschanz, F N, Kotsonis
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