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<br />
interpretati<strong>on</strong><br />
• EuropaBio Members appreciate that EFSA has commented <strong>on</strong> the<br />
imperfect relati<strong>on</strong>ship between statistical significance and<br />
toxicological relevance in the final versi<strong>on</strong> of the guidance.<br />
• However, without feedback from EFSA regarding the flexibility that<br />
will be permitted in overall design, some c<strong>on</strong>cerns about the<br />
prominence of the statistical analysis persist.<br />
• EFSA (2011b) recently stated, “Many researchers incorrectly c<strong>on</strong>clude<br />
that any statistically significant effect is biologically relevant...”<br />
– This gives EuropaBio Members c<strong>on</strong>fidence that EFSA c<strong>on</strong>siders statistical analysis<br />
<strong>on</strong>e tool of many to be used to identify toxicologically-relevant differences.<br />
• The scientific training of toxicologists, and their experience in<br />
interpreting data, must ultimately determine the relati<strong>on</strong>ship<br />
between the finding and treatment with the test substance.<br />
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