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See Latest ArticlesA New Approach to Managing Safety Information in Clinical Trials
PharmExec, 09/23/09
Safety used to be widely seen as a 'sales prevention' tool. Thankfully that has changed recently. But is it still viewed the same way in clinical trials? The Switzerland–based working group Council for International Organisations of Medical Sciences recently produced a paper on this subject, discussing what pharmaceutical companies can do to embrace drug safety in clinical trials. CIOMS says that there is a need to incorporate newer approaches for managing safety information in the clinical trial setting, and to adapt the methods and tools used in post–approval pharmacovigilance to the early and late stages of pre–approval development of medicinal products.
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A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimers disease: a post hoc analysis
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