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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2. Presentati<strong>on</strong> of results <strong>on</strong><br />
the standardised scale<br />
• When results are presented <strong>on</strong> the standardised<br />
scale all studies of the same design will appear to<br />
be equally sensitive regardless of any differences in<br />
underlying variability.<br />
• The guidance states that “Changes in endpoints<br />
…must also be evaluated with respect to normal<br />
biological variati<strong>on</strong> of the endpoints”; this can be<br />
d<strong>on</strong>e <strong>on</strong> the scale of original units but not <strong>on</strong> the<br />
standardised scale.<br />
44