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[Post-marketing surveillance].
Nederlands tijdschrift voor geneeskunde, 1996Onlangs deed Roos in dit tijdschift een oproep aan de medische professie collectief te weigeren deel te nemen aan post-marketing surveillance (PMS) (). Hieruit blijkt dat er nogal wat verwarring bestaat over de definitie van PMS. Wij zouden de door hem beschreven vorm, waarbij artsen onder het mom van PMS een geldelijke beloning ontvangen voor hun ...
de Koning, G. H. P. +2 more
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Post‐marketing surveillance of buprenorphine
Pharmacoepidemiology and Drug Safety, 2004AbstractPurposeThis study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long‐term treatment of opiate dependence.MethodsThe current ...
Rajat, Ray +4 more
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The rationale for a post-marketing surveillance*
Human Reproduction, 1987Post-marketing surveillance is essential in order to protect patients against avoidable risks from medication. Complete assessment of a drug cannot, for practical reasons, be made before marketing. There are several methods which can be used in post-marketing surveillance.
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Clinical trials in post-marketing surveillance of drugs
Contemporary Clinical Trials, 1982Abstract Based on a literature review, the value of clinical trials as a method for satisfying the objectives of a post-marketing drug surveillance (PMS) system is discussed. Although clinical trials serve an important role in this system, it is shown that other methods must also be incorporated to meet all of the objectives of PMS.
E O'Brian Smith
exaly +3 more sources
1988
When a new drug is released for general therapeutic use, little is known about its potential adverse effects. Premarketing clinical trials include small numbers of patients and thus rare adverse effects may not be detected. Their duration is short, when compared with the potential future routine clinical use of the drug, and thus adverse effects due to
J.-R. Laporte, X. Carné, D. Capellà
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When a new drug is released for general therapeutic use, little is known about its potential adverse effects. Premarketing clinical trials include small numbers of patients and thus rare adverse effects may not be detected. Their duration is short, when compared with the potential future routine clinical use of the drug, and thus adverse effects due to
J.-R. Laporte, X. Carné, D. Capellà
openaire +1 more source
Triangle; the Sandoz journal of medical science, 1981
The term post-marketing surveillance is a term which should be applied to all forms of monitoring marketed drugs for all aspects of their potential to produce adverse reactions.
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The term post-marketing surveillance is a term which should be applied to all forms of monitoring marketed drugs for all aspects of their potential to produce adverse reactions.
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Post-market surveillance of medical devices: A review
Technology and Health Care, 2022BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements ...
Almir, Badnjević +3 more
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Optimization of the post-marketing surveillance procedure
Annales de biologie clinique, 2017Ceux qui utilisent les dispositifs medicaux pendant leurs activites quotidiennes ne pensent pas forcement aux processus reglementaires qui precedent et suivent la mise en vente de ces dispositifs. Ces processus sont cependant essentiels a la securite des patients. Il est donc rassurant que les organismes regulateurs deviennent de plus en plus exigeants
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Post-marketing surveillance of oral contraceptives*
Human Reproduction, 1986Problems arise in the post-market surveillance of the possible long-term effects of oral contraceptives. These drugs are taken by very large numbers of people, in various doses, types and duration. One aspect is considered in this paper, the effects on pregnancy of these drugs taken before conception.
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Post-Marketing Surveillance of the Safety of Levofloxacin in Japan
Chemotherapy, 2007<i>Background:</i> Central nervous system reactions to new quinolones, such as convulsions due to interaction with nonsteroidal anti-inflammatory drugs (NSAIDS), have attracted increased attention in Japan. <i>Methods:</i> The safety of levofloxacin (LVX) was investigated in Japan by post-marketing surveillance and reviewing ...
Hiroki, Yamaguchi +6 more
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