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: 596

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,781 posts in 4,196 threads, 1,358 registered users;
online 10 (0 registered, 10 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 15:08 CEST

Multivariate analysis: A means of finding the answer
when you don’t know the question.    Stephen Senn

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