Bioequivalence and Bioavailability Forum • Linear model and Fieller…

Linear model and Fieller… [Power / Sample Size]

posted by Anu – India, 2013-10-04 15:16 (4652 d 02:46 ago) – Posting: # 11610
Views: 9,207

Hi all,

Greetings!

Kindly check the link Urine Analysis

According to our data we carried out a Pilot study on 21 Subjects and the Results for Excretion were as follows:

Refernce Formulation (LSM,SD)=(12.225,0.171)
Test Formulation (LSM,SD)=(11.540,0.171)

PD measure...Test-Reference....90% CI ±20% limit of....TestReference 90% CI Average
daily
urinary
excretion ... -0.69...... -1.07 to -0.30 ..... -2.44 to 2.44

As for the calculation of Pivotol study sample size we require (CV %, Point Estimate (T/R)) from Pilot study usually.
I have no idea how to go for the sample size calculation for this study from pilot results so available. :confused:

How we can calculate sample size for Pivotal Study in this case?

Also in the given link dint get how they have calculated, PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).
The numbers in red. Which in our study is (-2.44 to 2.44) :confused:

How the calculations done?

Thanks in advance

Anu

Complete thread:

Sample Size Anu 2013-09-04 07:03
- Sample Size Dr_Dan 2013-09-04 09:52
- Linear model and Fieller… Helmut 2013-09-04 13:20
  - Linear model and Fieller… jag009 2013-09-04 17:23
    - Linear model and Fieller…Anu 2013-10-04 13:16
      - Linear model and 80–120% Helmut 2013-10-04 15:20
        
        Linear model and 80–120% Anu 2013-10-07 09:59
        
        CVintra < CVtotal? Helmut 2013-10-07 14:14