Bioequivalence and Bioavailability Forum

Selection of samples for Incurred Sample Reanalysis [Regulatives / Guidelines]

posted by Ken Peh – Malaysia, 2014-05-28 15:56 (4409 d 09:16 ago) – Posting: # 13014
Views: 3,112

Dear Helmut and Ohlbe,

Thanks to both of you for the suggestions.

Is it necessary to pick samples of all the subjects for ISR ? For example, if we have 30 subjects, do we need to run ISR of all the 30 subjects ? Can we have ISR from 24 subjects as long as we fulfill the requirement of the numbers in the guideline ?

Kindly comment.

Thank you.

Regards,
Ken

Complete thread:

• Selection of samples for Incurred Sample Reanalysis Ken Peh 2014-05-22 19:42 
  • Selection of samples for Incurred Sample Reanalysis Helmut 2014-05-23 13:12
    • Selection of samples for Incurred Sample Reanalysis Ohlbe 2014-05-24 20:16
      • Selection of samples for Incurred Sample ReanalysisKen Peh 2014-05-28 13:56
        • Selection of samples for Incurred Sample Reanalysis Ohlbe 2014-05-28 14:27