Baseline correction vs non-baseline correction [Regulatives / Guidelines]

posted by Lucas – Brazil, 2015-09-16 16:16 (3439 d 12:44 ago) – Posting: # 15405
Views: 23,259

Hello John!

I don't think that this is a stupid question at all. I've always wondered that. When you ask for both results but says that only the corrected should be considered in BE determination, then why present both??

I'm not sure if in the US both are mandatory, but here only corrected data determine BE, and uncorrected should be presented. That's maybe only to confuse, because I've seen different conclusions for corrected and uncorrected data...

I'm also not sure about the correction based on three basal sampling points, taken very close to the drug administration. We've conducted a estradiol study recently and the basal levels for it were a nightmare, really really bizarre. We observed curves that were almost completely below the basal level, implying that the basal level is not even near constant through the Pk sampling schedule.

So if anyone can shed a light on that, I would also be pleased.

:confused:
thx

Lucas

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