Bioequivalence and Bioavailability Forum

❝ ICH M13A does not cover replicate design (M13C will). Therefore, Section 2.3.5 of Health Canada’s guidance is still applicable.

Thank you sir.

yes agree sir. But in full replicate design if subject found outlier in particular period for Cmax and AUC parameters of Swr calculation, shall we remove that particular period data from PK & Statistical analysis or from entire study periods?

can you please mention what are the scenarios we can fallow for Canada full replicate design to exclude the subject from pharmacokinetic and statistical analysis.

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]