نتایج جستجو برای: post marketing
تعداد نتایج: 454210 فیلتر نتایج به سال:
In the European Union the term pharmacovigilance is normally used to describe post-marketing or, more precisely, post-approval experience after the regulatory approval of drugs and their introduction to the market under defined conditions. The term describes activities used to gather information on the effects of medicinal products, with emphasis on those aspects which have not, or could not ha...
The European process for assessment of pharmaceutical products is complex and presents with diVerent levels. There is the European level with two major procedures resulting in decisions on approval after applications to market a pharmaceutical product in European countries. One is the centralised procedure organised by the European Medicines Evaluation Agency (EMEA). The other one is the mutual...
INTRODUCTION Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening')...
PURPOSE Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, ...
The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveillance because they are often misused, abused, and diverted. These medications include opioid analgesics, stimulants, sedative-hypnotics, muscle relaxants, anticonvulsants and other drug classes. Their advers...
PURPOSE Rotarix(TM) was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that Rotarix(TM) may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and Rotarix(TM) vaccination in Japan. METHODS All IS cases spontaneously reported post-vaccination (Brighton collaboration levels 1, 2, and 3) we...
The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as reports of potential short- and long-term complications such as infection and malignancy. These complications are especially worrisome in children who often have serial exposures to multiple immunomodulatory products. Post-marketing surveil...
For more than a decade a growing number of academics have questioned the basis and value of many core marketing principles and have brought into question the credibility of the dominant historical account of the development of marketing (Fitchett 2005). Despite this criticism, and the growing disdain heaped upon marketers, change is notoriously slow in marketing education. This paper traces the...
Idarucizumab is the first reversal agent approved for the direct thrombin inhibitor dabigatran. The authors summarize the findings from the clinical trial series and describe case reports, post-marketing data, and ongoing studies.
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