Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
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3. Summary statistics and<br />
raw analysis outputs<br />
• EuropaBio Members’ understanding is that EFSA wishes to see<br />
results presented both in terms of means and p-values, and<br />
differences and 95% c<strong>on</strong>fidence intervals.<br />
• However, some requirements are less clear, and others (e.g., the<br />
median) seem to be of questi<strong>on</strong>able value in most cases.<br />
• It is the opini<strong>on</strong> of EuropaBio Members that the following<br />
summary statistics would generally be appropriate:<br />
– Mean, min, max and SD for each treatment group.<br />
– P-values for all fixed effects and specific c<strong>on</strong>trasts.<br />
– Point estimate of the difference between GM and n<strong>on</strong>-GM together with<br />
95% c<strong>on</strong>fidence interval for the difference.<br />
• EuropaBio Members seek c<strong>on</strong>firmati<strong>on</strong> from EFSA as to whether<br />
the above list is acceptable.<br />
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