NTI drug with high CV? [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2019-12-14 16:11 (596 d 05:57 ago) – Posting: # 20976
Views: 1,550

Hi Mikalai,

» What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%?

Unless the drug belongs to the last generation anticoagulants (dabigatran, rivaroxaban) that's a contradiction. NTIDs show low variability. Otherwise, there would have been serious problems in phase III: toxicity, lacking efficacy – no approval – end of story.
BTW, the acceptance limits for NTIDs in the EEA are 90.00–111.11%.

» Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative

library(PowerTOST)
sampleN.TOST(CV = 0.3, theta1 = 0.9, design = "2x2x2")
sampleN.TOST(CV = 0.3, theta1 = 0.9, design = "2x2x4")

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 10 (0 registered, 10 guests [including 2 identified bots]).
Forum time: Sunday 23:09 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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