CVinter zero?! [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2012-08-20 01:57 (5047 d 12:14 ago) – Posting: # 9083
Views: 3,539

Hi Ioana!

❝ The CRO reported also the values obtained for intra- subject variability for test and also for reference product.


The former is nice to know and only the latter needed for scaling.

❝ But the reported value is identical with Geo CV of mean Cmax for the tested products.


That’s a crude estimate of CVtotal. Its value could only be identical to CVintra if CVinter = 0… I guess the CRO screwed up.

❝ More than that, these values are almost double compared to those reported for reference in literature.


Unlikely, but not impossible. Comparisons (especially of HVDs/HVDPs) between study are always problematic. BTW, do you trust in their bioanalytics?

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
107 visitors (0 registered, 107 guests [including 19 identified bots]).
Forum time: 14:11 CEST (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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