Bioequivalence and Bioavailability Forum

Dear all,

I need your expertise regarding the estimation of the CVintra. Indeed, I am aware that the within subject CV should be calculed based on the sw² obtained following a full (or partially) replicate design study but my question is:

- is it relevant to estimate the within subject CV based on the MSE obtained following a classical CO study (analysed with the EMA requiments e.g period, formulation and subject within sequence as fixed effect)? I precise that it is just an estimation to have an idea if it is relevant to performed a replicate design study or not.

I heard in a symposium that the CV obtained from the MSE should be a good estimator of the real within subject CV, could you confirm ? (or not )

Thank you,
Kind regards,

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