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

4. Should males and females
be analysed together?
• Reasons for analysing genders separately (continued):
– Analysis by gender is the standard approach in toxicology.
– Certain endpoints (e.g., testes or uterus weights) are limited to
one gender and thus necessitate separate analyses by default.
– Results from the power investigation show that powers based
on gender-specific analyses are generally more than adequate
for the designated purpose.
• EuropaBio Members therefore recommend analysing
genders separately.
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