Bioequivalence and Bioavailability Forum

Missing values [Study Performance]

posted by martin – Austria, 2008-07-29 15:56 (6127 d 07:04 ago) – Posting: # 2092
Views: 16,866

Dear Ratnakar!

according to my point of view you have to define of a full analysis data set (FADS) and a per-protocol analysis data set (PADS) according to ICH E9.

for FADS you have to analyze the data as they are whereas for the PADS you can specify exclusion/inclusion criteria (e.g. a minimum of x time points prior Tmax and a minimum of y time points after Tmax) where Tmax can be calculated from data of a pilot study.

best regards

martin

Complete thread:

Missing values ratnakar1811 2008-04-02 14:07 [Study Performance]
- Missing values Helmut 2008-04-02 14:54
  - Missing values atish_azad 2008-07-29 11:03
    - Missing values ElMaestro 2008-07-29 11:21
      - Missing values Helmut 2008-07-29 21:40
        
        Missing values ElMaestro 2008-07-31 10:38
        
        Missing values Helmut 2008-07-31 14:36
    - Missing values Helmut 2008-07-29 21:18
- Missing valuesmartin 2008-07-29 13:56
  - Missing values Helmut 2008-07-29 22:18
    - Missing values martin 2008-07-30 10:28
      - ITT vs. PP data sets Helmut 2008-07-30 13:30
      - Missing values d_labes 2008-07-30 13:39
        
        Missing values Helmut 2008-07-30 14:34
        Missing values martin 2008-07-30 14:50
        
        Missing values Helmut 2008-07-30 17:14
        
        Missing values d_labes 2008-07-31 09:18

Missing values [Study Per­for­mance]

Complete thread:

Missing values [Study Performance]