AUCsingle dose/Ctrough [Power / Sample Size]

posted by Sundar.M – India, 2018-12-20 09:30  – Posting: # 19700
Views: 566

Dear all,

I came across one of the report that calculated the sample size for SS study, the sample size calculation is based on the variability obtained from the results of AUCsingle dose variability/Ctrough (simulated) variability.

In the above context, what kind of PK information will get to know when we take ratio of variability of AUC observed after single dose vs.variability from simulated Ctrough (from that single dose study).

Your feedback is highly appreciated.


Thanks
MSMN

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,340 registered users;
online 8 (1 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 16:48 CEST

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5