CV values in BE studies: intra, or inter, or total? [Study As­sess­ment]

posted by jag009  – NJ, 2018-01-20 19:18  – Posting: # 18232
Views: 4,880

Hi

» Ln Cmax(ng/ml) […]: Mean (CV) = 1212.09 (28.7)

I checked the table... That's not the intrasubject CV. That's just the CV from (SD/Mean)*100.
Same answer from your 2nd question (I didn't look but I assume you were referring to a result that has similar output format as in Mean(CV)).

» Which kind of CV is performed in my examples? And in general which kind of CV is usually performed in reports of BE studies? Is it CVintra, or CVinter, or CVtotal?

In the world of BE we deal with CVintra because that's what we are interested in since that's one of the driving force in computing the 90% CI goal post for BE. We do care about inter and CVtotal as well depending on the type of BE study design we are going after (crossover or parallel).

J

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