Baseline sampling [Regulatives / Guidelines]

posted by NK – India, 2019-06-26 09:25 (2184 d 11:34 ago) – Posting: # 20360
Views: 4,225

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
49 visitors (0 registered, 49 guests [including 36 identified bots]).
Forum time: 20:59 CEST (Europe/Vienna)

Truth and clarity are complementary.    Niels Bohr

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5