Bioequivalence and Bioavailability Forum

Dear Smitha,

❝ How appropriate is it to generate another set of data for a critical PK parameter as Cmax? (even if the guidelines indicate that these values should not be used for study conclusion).

I don't see a real problem here: as you say, the guidelines clearly indicate that the ISR value should not be used for the PK/stats.

Actually, it sort of helps to avoid some other issues. If you write in your SOP that you will systematically repeat the Cmax sample, there will be no discussion regarding how you selected the samples to be re-analysed and possible bias in sample selection.