نتایج جستجو برای: post marketing surveillance
تعداد نتایج: 538652 فیلتر نتایج به سال:
OBJECTIVES To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. DESIGN Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. SETTING Notifications obtained through freedom of informatio...
Safety, cost, and eVectiveness studies are critically important for definitive assessment of disease modifying drugs (DMARDs), particularly when new mechanisms of drug action are likely to be present. This requires post-marketing surveillance, as these dimensions cannot be adequately assessed in pre-marketing studies. “Post-marketing surveillance”, in our definition, is “the asking and answerin...
OBJECTIVE The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in Japan in the future. METHODS We comprehensively reviewed reports regarding gefitinib published during the period from 2000 to 2006 by regulatory...
Recently, several drugs for non-cardiovascular diseases have ceased marketing because of cardiovascular risk, highlighting the importance of evaluating the cardiovascular safety of new drugs even if not intended for cardiovascular diseases. Assessing and ensuring acceptable cardiovascular safety of non-cardiovascular drugs is difficult; nonetheless, governmental regulatory agencies are likely t...
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