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Beyond ICH Q1E Opening Remarks Beyond ICH Q1E Opening Remarks

Beyond ICH Q1E Opening Remarks - PowerPoint Presentation

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Uploaded On 2018-12-24

Beyond ICH Q1E Opening Remarks - PPT Presentation

Rebecca Elliott Senior Research Scientist Eli Lilly and Company MBSW 2013 ICH Q1E Required analysis for setting specifications Statistical details BUT what does the analysis tell us The more data the narrower the interval on the regression line the longer the dating ID: 745552

stability change assay data change stability data assay day batches variability statistical routine dating analysis significance samples estimating results

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