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

1. Toxicological endpoints for
power calculations (continued)
• The toxicological relevance of any differences observed will be
determined on a case-by-case basis.
– Alkaline phosphatase factors: AST levels, ALT levels, liver weight, liver
histopathology, etc.
• All effect sizes proposed have been considered on the scale of
original units.
– This is the scale that makes most sense to toxicologists as it provides
necessary context for evaluation of biological significance.
• Specifying effect sizes on the original units scale removes the
need to consider effect sizes on the standardised scale.
– To be discussed in greater detail later.
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