Bioequivalence and Bioavailability Forum

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• Concentration data from subjects withdrawn/ dropped will considered in statistical analysis on case to case bases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• If the subjects were withdrawn from the study due to the below mentioned concerns but not limited to
  • Self withdrawn from the study during the elimination phase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• If the subjects were withdrawn from the study due to AE in any phase of the study, those subjects will be excluded from statistical analysis.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