Don’t hurry; explore consequences [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2014-07-08 12:00 (2963 d 10:40 ago) – Posting: # 13237
Views: 10,904


» However, as you mentioned that by considering the obtained T/R ratio, a higher sample size would be required.
» Could you please let me know that what could be in approx sample size if study is repeated?

I strongly suggest not to use values obtained in the study hoping that you get exactly the same ones in a repeated one. They are estimates, not “carved in stone”. Consider reading one of my pre­sen­ta­tions about sample size estimation. You will see that in your case (similar CVs of AUC and Cmax) the ratio is more important. To give you a first idea (using exactly the values for AUC): 78 subjects for 80% power and 108 for 90%.
Get [image] / package PowerTOST and run a sensitivity analysis according to ICH E9:

The method by which the sample size is calculated should be given in the protocol, to­geth­er with the estimates of any quantities used in the calculations (such as variances, mean values, […] difference to be detected). The basis of these estimates should also be given. It is impor­tant to investigate the sensitivity of the sample size estimate to a vari­ety of deviations from these assumptions and this may be facilitated by providing a range of sample sizes appro­pri­ate for a reasonable range of deviations from as­sump­tions.

» unique_one.

Always remember that you are absolutely unique.
   Just like everyone else.
     Margaret Mead

Dif-tor heh smusma 🖖 [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Thursday 22:40 CEST (Europe/Vienna)

On two occasions I have been asked,—“Pray, Mr. Babbage,
if you put into the machine wrong figures,…
will the right answers come out?”
I am not able rightly to apprehend the kind of confusion of ideas
that could provoke such a question.    Charles Babbage

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