AUCsingle dose/Ctrough [Power / Sample Size]

posted by Sundar.M – India, 2018-12-20 09:30 (955 d 12:28 ago) – Posting: # 19700
Views: 1,518

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.


Complete thread:

 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Sunday 22:58 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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