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I would like to know your opinion regarding the method for the evaluation of linearity defined in the new EMA guideline on BE (section 4.1.6 page 12):
"Assessment of linearity will consider whether differences in dose-adjusted AUC meet a criterion of +/-25%".
This is a quite obscure sentence describing the method commonly used for this assessment (90% CI of the ratio between dose-adjusted AUCs from the ANOVA model within the limits 0.8-1.25) or it is suggesting a totally different approach?
Thank you in avdance for your help.
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