Dose based on m² [General Sta­tis­tics]

posted by VK – Russia, 2013-07-17 18:17 (3798 d 23:55 ago) – Posting: # 11000
Views: 8,430

Dear Dr_Dan,

Thank you for the prompt reply. Please let me comment below:

❝ What do you mean by "We did regular calculations"?

We calculated PK parameters (Cmax, AUClast and Cmax/AUClast), correspodning 90% CIs and ANOVA (as required in Russia) for 100% of patients.

❝ If you had choosen

❝ 70% received 4x25mg

❝ 30% received either 3x25mg or 5x25mg

❝ Then 100% of the subjects could be evaluated.

This is our case. To shed more light on the design - 70% receieved 4*500mg, while 30% received either 3*500mg or 5*500 mg. Hence the only strength was 500, while the doses were different.

So the regulatory body experts tell us that we should use 70% for the calculation because the received one dose. That is why I looking for some kind of GL/textbook I could refer our experts.



Complete thread:

UA Flag
 Admin contact
22,824 posts in 4,786 threads, 1,633 registered users;
35 visitors (0 registered, 35 guests [including 8 identified bots]).
Forum time: 17:13 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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