Bioequivalence and Bioavailability Forum

SABE Reference Variability and CI Computation [General Statistics]

posted by preyes323 – 2010-07-12 19:12 (5825 d 20:07 ago) – Posting: # 5608
Views: 18,202

Hi,

I am currently studying on Pharmacokinetic Analysis. My teacher gave me a sample Cmax Data for use in studying. I was tasked to compute for the bioequivalence using the protocol in this link:

FDA Draft Guideline

I got the following values for the reference variability and CI.

reference = 0.378573
CI = 34.55646

According to him these are the wrong values. It should have been 0.452 and -0.16794 respectively.

I have tried recomputing it a number of times already. I also used the SAS code as indicated in the guide. Am I missing something? Is there supposed to be some other implied computation that I am not doing? Below is a link to some of the files I have used for computation as well as the sample data he gave.

Thank you very much in advance to anyone who can help me.

Thanks and Regards,
Paolo

Cmax Reference Variability.zip

Complete thread:

SABE Reference Variability and CI Computationpreyes323 2010-07-12 17:12
- Dataset Helmut 2010-07-12 17:26
  - Dataset preyes323 2010-07-12 18:20
    - Data format Helmut 2010-07-12 18:38
      - Data format preyes323 2010-07-13 01:16
        
        SAS and/or Phoenix/WinNonlin-experts around? Helmut 2010-07-13 02:29
        
        Phoenix/WinNonlin-experts around? d_labes 2010-07-13 12:15
        
        Phoenix/WinNonlin-experts around? Helmut 2010-07-13 13:42
        
        Mixed interest d_labes 2010-07-13 15:11
        
        Mixed interest Helmut 2010-07-13 19:19
        
        lme() answer and beyond ... d_labes 2010-07-14 10:41
        
        lme() answer and beyond ... Helmut 2010-07-14 13:47
        
        AIC, BIC and that all ... d_labes 2010-07-15 12:01
        
        To Err is Human d_labes 2010-07-13 11:51
        
        To Err is Human, but... Helmut 2010-07-13 13:45
        
        ... to Arr is Pirate d_labes 2010-07-13 15:47
        
        Brilliant page!!! ElMaestro 2010-07-14 21:03
        
        To Err is Human preyes323 2010-07-14 14:45
        
        Heads up! Helmut 2010-07-14 15:17
        To Err is Teacher d_labes 2010-07-15 11:05
        
        To Err is Human preyes323 2010-07-16 02:28
        
        To Err is Human d_labes 2010-07-16 10:42
        
        To Err is Human preyes323 2010-07-17 11:14
        
        Regulatory constants d_labes 2010-07-19 10:00
        
        Data format ElMaestro 2011-02-06 11:54
        
        SAS System Viewer Helmut 2011-02-06 13:02

SABE Reference Variability and CI Computation [General Sta­tis­tics]

Complete thread:

SABE Reference Variability and CI Computation [General Statistics]