Baseline sampling [Regulatives / Guidelines]

posted by NK – India, 2019-06-26 07:25  – Posting: # 20360
Views: 623

Hello everyone,

I have a question with regards to FDA OGD guidance of Dihydroergotamine Nasal Spray" dated February 2019.

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 nor available in the diet, then why baseline value is required?

If it is required, what should be baseline sampling time points (-1h or -30 min or -15 min ...)?

Thanks in advance.

Regards
NK


Edit: URL corrected. [Helmut]

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