Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-06-26 12:10 (1957 d 18:01 ago) – Posting: # 20361
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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. ;-)

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