AUCrefTmax (Health Canada) [Regulatives / Guidelines]
❝ For an NSAID immediate release Soft gelatin capsules with two way crossover study although if AUCt and Cmax are with in acceptance limits and there is no difference in median Tmax of both Test and Reference, but for AUCrefTmax 90% CI is not within 80-125% (will Health Canada accept the BE study).
- Rapid onset of effect is important. According to the guidance AUCrefTmax should be reported.
IMHO, a statistical comparison is not required.
- For Cmax only the point estimate has to lie within 80.0–125.0%.
If the CI passes 80.0–125.0%, nice to know but not required.
- What does you protocol say?
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