Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

Introduction
• EFSA has stated that its guidance on repeated-<strong>dose</strong> <strong>90</strong>-<strong>day</strong> oral toxicity
studies in rodents on whole food/feed is “not intended to provide
prescriptive experimental test protocols.”
• EuropaBio Members agree there should be flexibility in the design of future
studies with whole food/feed and that justification for the approach to the
study is important.
• The new EFSA guideline will:
– Impact design, conduct, analysis and interpretation both toxicologically and
statistically.
– Create challenges that require additional discussion with EFSA and other
stakeholders in the EU.
• EuropaBio Members appreciate the opportunity to discuss these new
challenges, and their proposed solutions to them, with key stakeholders in
the EU.
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