Bioequivalence and Bioavailability Forum

Hi NK,

❝ The guidance specified that "baseline corrected PK data of AUC and Cmax should be used for bio-equivalence calculation"

❝ As per my understanding, Dihydroergotamine is neither endogenous …

Correct.

❝ … nor available in the diet, …

Oh yes! Even when, it would practically not absorbed.

❝ … then why baseline value is required?

IMHO, a bizarre idea. Ask the FDA.

❝ If it is required, …

It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.

❝ … what should be baseline sampling time points (-1h or -30 min or -15 min ...)?

The FDA’s general approach for a stable baseline is subtracting the mean of {-1 h, -0.5 h, pre-dose}. In your case likely it would be BQL anyhow.