Bioequivalence and Bioavailability Forum • Calculation

Calculation [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-11-30 12:35 (5321 d 14:00 ago) – Posting: # 7753
Views: 16,502

Hi sangeeta,

❝ Thanks for your reply. Did you mean fitting model for individual subjects data?

❝ But as per the guideline we should fit for mean of PD response for each dose.

I think you will have to resample your dataset 500 etc times. For each resample you fit the model and extract an F. On basis of the 500 etc F values you derive your bootstrap confidence interval.

Good luck.

—
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
        
        Calculation ElMaestro 2011-11-29 18:09
        
        Calculation sangeeta 2011-11-29 18:30
        
        CalculationElMaestro 2011-11-30 11:35