Mikalai
★    

Belarus,
2019-12-14 15:39
(890 d 17:55 ago)

Posting: # 20975
Views: 2,496
 

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

Dear all.
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%? Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative
Best regards.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-12-14 16:11
(890 d 17:22 ago)

@ Mikalai
Posting: # 20976
Views: 1,878
 

 NTI drug with high CV?

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 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 18 (1 registered, 17 guests [including 8 identified bots]).
Forum time: Monday 10:34 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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