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. Secti<strong>on</strong><br />
summary/discussi<strong>on</strong><br />
• Please clarify if a separate Statistical Analysis Plan is<br />
mandatory or if the level of detail that can be<br />
presented in the study protocol is adequate.<br />
• Does EFSA regard the summary statistics proposed by<br />
EuropaBio Members as suitable?<br />
• Please clarify whether raw data in electr<strong>on</strong>ic format is<br />
a default requirement or “<strong>on</strong> request”.<br />
• Please clarify whether the statistical analysis<br />
programs, logs and outputs are a default requirement<br />
or “<strong>on</strong> request”.<br />
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