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Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals: Post Hoc Analysis of Japanese Patients (MELODY Study) [PDF]
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Brief of Amici Curiae Former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler in Support of Respondent, Wyeth v. Levine, No. 06-1249 (U.S. Aug. 14, 2008) [PDF]
, 2008 Sabbeth, Kathryn A., Vladeck, David C.
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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
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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
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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
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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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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 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.
Cynthia L, Arfken, Theodore J, Cicero
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Postmarketing Surveillance: Beyond medWatch
JAMA: The Journal of the American Medical Association, 1993To the Editor. —As one who has actively participated in adverse effects surveillance over the past 10 years, 1,2 I wish to applaud the new Food and Drug Administration (FDA)MEDWATCHinitiative. 3 The FDA commissioner and his staff are to be congratulated on recognizing that major efforts must be made to heighten awareness of the importance of reporting
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