Input for CV when small first-in-man has been run [Power / Sample Size]

posted by Rocco_M – Mexico, 2019-09-03 18:45  – Posting: # 20537
Views: 3,384

Hi all,

I have a question about initial input for CV into a sample size calculation comparing two formulations when all that has been run is a single study, say, a first in man. Since it is not correct to use sd/mean from the first formulation as your CV, but if it is all you have (say, you measured log(AUC) from ten patients for a single formulation (ie, only for the reference), what would you input as CV for a subsequent parallel (say) study between this formulation and another one not yet available) in order to estimate sample size?

I see people will typically enter sample sd / sample mean of the single formulation, but I feel this is incorrect.

Complete thread:

Activity
 Admin contact
20,797 posts in 4,354 threads, 1,445 registered users;
online 11 (1 registered, 10 guests [including 5 identified bots]).
Forum time: 13:17 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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