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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

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