Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-06-26 10:10  – Posting: # 20361
Views: 814

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. ;-)

Cheers,
Helmut Schütz
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