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: 1,243

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
19,871 posts in 4,212 threads, 1,364 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 12:51 CEST

A drug is not bad. A drug is a chemical compound.
The problem comes in when people who take drugs treat them
like a license to behave like an asshole.    Frank Zappa

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