Bioequivalence and Bioavailability Forum • Calculation

Calculation [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-11-29 19:09 (5327 d 02:31 ago) – Posting: # 7751
Views: 17,451

Hi sangeeta,

❝ I tried to fit the model as in guideline by pooling all subjects for mean of PD response for reference. Here I have only 3 observations, 2 observations for reference since we have 2 doses and 1 observation for baseline (0 mg). I could not fit the model in SAS since I have only 3 observations. I am not clear here while taking means from guideline perspective.

I think you have to do bootstrapping. So no averaging. Sample full data sets from the in vivo data listing 500 times with resampling and evaluate 500 times etc.

—
Pass or fail!
ElMaestro

Complete thread:

Orlistat Bioequivalence KR 2010-04-23 06:14
- To Abreviate or not to Abreviate d_labes 2010-04-23 09:28
  - What was really meant ElMaestro 2010-04-23 09:50
    - OGD Guidance Helmut 2010-04-23 12:42
  - To Abreviate or not to Abreviate KR 2010-04-23 15:01
    - Calm and serene d_labes 2010-04-23 15:47
    - To Abreviate or not to Abreviate ElMaestro 2010-04-24 08:16
      - To Abreviate or not to Abreviate KR 2010-04-26 06:03
        
        To Abreviate or not to Abreviate GSTATS 2010-05-27 18:30
        
        My lack of understanding ElMaestro 2010-05-28 00:54
        
        My lack of understanding GSTATS 2010-05-28 17:03
        
        My lack of understanding ElMaestro 2010-05-29 03:32
        
        My lack of understanding GSTATS 2010-05-29 05:28
        
        My lack of understanding KR 2010-05-31 08:51
        
        My lack of understanding ElMaestro 2010-06-01 16:13
        
        Calculation sangeeta 2011-11-29 17:58
        
        CalculationElMaestro 2011-11-29 18:09
        
        Calculation sangeeta 2011-11-29 18:30
        
        Calculation ElMaestro 2011-11-30 11:35