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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1. Toxicological endpoints<br />
for power calculati<strong>on</strong>s<br />
• The MTD has also been defined as the <str<strong>on</strong>g>dose</str<strong>on</strong>g><br />
that, “…does not produce mortality, clinical<br />
signs of toxicity, or pathologic lesi<strong>on</strong>s…”<br />
(Dorato et al., 2008; S<strong>on</strong>tag, 1976).<br />
• Hence, it is a <str<strong>on</strong>g>dose</str<strong>on</strong>g> that elicits signs more<br />
subtle than overt toxicity.<br />
• Endpoints and effect sizes are taken from the<br />
indicated guidance documents.<br />
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