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Sacrificial Lambs: Compensating First Subscribers to FDA-approved Medications for Postmarketing Injuries Resulting from Unlabeled Adverse Events [PDF]
, 2013 Miller, Rodney K.
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British Journal of Dermatology, 2021
Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long‐term robust studies.
M. Lebwohl +11 more
semanticscholar +1 more source
Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long‐term robust studies.
M. Lebwohl +11 more
semanticscholar +1 more source
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 ...
Jacqueline S. Gardner +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 ...
Harriett H. Butchko +2 more
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The Pediatric Infectious Disease Journal, 2020
BACKGROUND In 2015, infliximab was approved for the treatment of patients with intravenous immunoglobulin-refractory Kawasaki disease (KD) in Japan. However, limited real-world data exist on the usefulness of infliximab for acute KD patients.
M. Miura +9 more
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BACKGROUND In 2015, infliximab was approved for the treatment of patients with intravenous immunoglobulin-refractory Kawasaki disease (KD) in Japan. However, limited real-world data exist on the usefulness of infliximab for acute KD patients.
M. Miura +9 more
semanticscholar +1 more source
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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An evaluation of statistical approaches to postmarketing surveillance
Statistics in Medicine, 2020Safety of medical products presents a serious concern worldwide. Surveillance systems of postmarket medical products have been established for continual monitoring of adverse events (AEs) in many countries, and the proliferation of electronic health ...
Yuxin Ding, M. Markatou, R. Ball
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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
openaire +2 more sources