Bioequivalence and Bioavailability Forum 12:08 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Sample Size Estimation -Replicate design- BE limits [Power / Sample Size]

posted by cakhatri - India, 2017-11-30 09:44  - Posting: # 18024
Views: 7,194

Dear All,

I would like to know

1.What BE limits should be taken into consideration while estimating sample size for replicate design studies for USFDA & EMA.

Should it be 80-125% ? We normally use FARTSSIE

Why the Question

1. For a product with 51% ISCV (from a completed partial replicate study UKMHRA) by using FARTSSIE we arrived at different sample size for EMA

- Sample size estimated = 27 (80% Power, 95-105% T/R, Method C1, BE Limits 69.84 to 143.19%)
- Sample size estimated = 76 (80% Power, 95-105% T/R, No reference Scaled BE Limits-80-125%)

Which sample size should we consider for pivotal study

Regards
Chirag

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,883 posts in 4,027 threads, 1,271 registered users;
online 30 (0 registered, 30 guests [including 26 identified bots]).

Those who make no mistakes are making the biggest mistakes of all –
they are attempting nothing new.    Anthony de Mello

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