26.08.2013 Views

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

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

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 />

14

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!