Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-08-24 01:18 CEST (UTC+2h)
 
sury
Junior

India,
2017-06-23 06:56

Posting: # 17497
Views: 564
 

 Handling the dropout and Withdrawl subjects in Statistical Analysis [General Sta­tis­tics]

Dear Helmut,

we are confused about the consideration of the data from the dropout and withdrawal Subjects in Statistical analysis. Currently we are considering the below mentioned points for the Exclusion of subjects in the Statistical Analysis
  • Concentration data from subjects withdrawn/ dropped will considered in statistical analysis on case to case bases
  • If the Subjects were dropped on his own reasons at elimination phase, they will be considered in statistical Analysis
  • If the subjects were withdrawn from the study due to the below mentioned concerns but not limited to
    • Self withdrawn from the study during the elimination phase
    • Found alcohol breath test positive during ambulatory visits
The subjects who fall under the above mentioned criteria will be included in statistical analysis if they provide evaluable PK data
  • If the subjects were withdrawn from the study due to AE in any phase of the study, those subjects will be excluded from statistical analysis.

Is the points valid that we are using for the exclusion of the subjects and any other suggestions/ exclusion criteria for performing the statistical analysis

Regards,
Surya
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,243 Posts in 3,687 Threads, 1,056 registered users;
21 users online (0 registered, 21 guests).

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed