Bioequivalence and Bioavailability Forum

Dear Helmut,

❝ In your posts you regularly use the phrase “We were told…” It would help to know who told you some­thing. A colleague, a regulator/inspector, the sponsor?

Inspector. The inspector of the recent inspection is kind enough to accept the use of weighting factor in BE study.

❝ Correct – not only allowed, but mandatory in most cases. Do you remember this thread?

Yes. I remember. I learned a lot from the thread and have started using weighting factor after that.

❝ You have to stick to what you stated in the protocol. You can recalculate samples as an additional analysis. No idea how regulators like that. In the future, go for a weighted calibration.

The protocol you refer to is study protocol or method validation protocol? We do not explain in detail the analytical method in the study protocol, which is submitted to ethical committee.

❝ No. You could use the raw data of the MV and update the validation/SOP.

Kindly explain "update the validation".

Thank you for your kind sharing.

Regards,
Ken