PharmPK Discussion - Linearity in the new EMA guideline

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On 7 Jul 2010 at 10:04:35, Stefano Vezzoli (bourne5321.-a-.gmail.com) sent the message


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.
 Stefano

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