Bioequivalence and Bioavailability Forum

How to calculate within subject standard deviation in fully replicate study design of carry over effect is present?

Eg. I am planning a full replicate single dose study in patients. Patients has to take medication at every 4 month. Pre-dose concentration in subsequent periods are observed below 5 % of Cmax or 0 in pilot study. If carryover effect is present in pivotal study but the pre-dose concentration is less than 5 % of Cmax, how should I calculate Swr for BE assessment?

After dosing, the plasma concentration reaches Cmax in about 4 hours and comes down below 5 % of Cmax in 2-3 days and remains stable from day 4 to 120 and is also the pre-dose concentration for subsequent period/s.

The primary PK parameters are Cmax, AUC0-t and AUC7-t

Thank you for your response in advance.

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Edit: Category changed; see also this post #1. [Helmut]