Shorter sampling interval in pilot - Good idea? [Design Issues]

posted by nobody – 2018-02-27 19:02  – Posting: # 18472
Views: 1,871

Hy!

Have a drug with "normal" half-life of some hours in the mean, but considerable variability (BOTH target params). So pilot will be huuuugh and fully replicate (planned: EU submission).

Sponsor wants to make a little cheaper by having only 24 h sampling in the pilot, but considerably longer in the pivotal trial.

Good idea? Regarding sample size estimation for the pivotal (including adjusted acceptance range for Cmax, but standard acceptance range for AUC...).

Any thoughts or numbers? :-)

Οὐδείς

Kindest regards, nobody

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,289 posts in 4,100 threads, 1,317 registered users;
online 8 (2 registered, 6 guests [including 5 identified bots]).

A refund for defective software might be nice,
except it would bankrupt the entire software industry
in the first year.    Andrew S. Tanenbaum

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