Bioequivalence and Bioavailability Forum

Dear Jay,

❝ I would like to know if quadratic equation can be used for bioequivalence

❝ study?

No objection that I know of, at least in Europe and US. This is common practice for LC/MS/MS.

❝ If yes, then whether any justification is required for the same or not.

IMHO no justification needed in the report, but you should have the raw data showing why you selected quadratic rather than linear during your method validation.

❝ Please note that the drug is relatively old

This makes no difference.

❝ and linear equation for the same is available.

If quadratic gives a better fit based on the residuals and their repartition, then no problem.

Regards
Ohlbe