New approaches to fill the methods gap in pharmacovigilance
New approaches to fill the methods gap in pharmacovigilance
New approaches to fill the methods gap in pharmacovigilance
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Long-term treatment: >6 monthsbuild<strong>in</strong>g <strong>the</strong> safety database for approval The number of patients treated for 6 months at dosagelevels <strong>in</strong>tended for cl<strong>in</strong>ical use, should be adequate <strong>to</strong>characterise <strong>the</strong> pattern of ADEs over time. (n=300-600) ADEs that <strong>in</strong>crease <strong>in</strong> frequency or severity with time orthat may occur only after > 6 months of treatment. (n=100treated for 1 year) <strong>to</strong>tal number of <strong>in</strong>dividuals treated with <strong>the</strong> <strong>in</strong>vestigationaldrug, <strong>in</strong>clud<strong>in</strong>g short-term exposure, will be about 1500.11
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