Bioequivalence and Bioavailability Forum • Selection of samples for Incurred Sample Reanalysis

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

posted by Ken Peh – Malaysia, 2014-05-22 21:42 (4414 d 05:05 ago) – Posting: # 12991
Views: 4,144

Dear All,

EMEA guideline mentions that "10% of the samples should be reanalysed in case the number of samples is less than 1000 samples and 5% of the number of samples exceeding 1000 samples. Furthermore, it is advised to obtain samples around Cmax and in the elimination phase".

I would be glad to have your feedback and comments on the following questions:

Do we have to take the samples of each and every subjects or it is sufficient as long as we can fulfill the no of samples required ? What is the right approach ?
It is advised to obtain samples around Cmax and in the elimination phase. Does it mean that around Cmax is at the absorption phase before Cmax ?

Your feedback is highly appreciated.

Thank you.

Regards,
Ken

Complete thread:

Selection of samples for Incurred Sample ReanalysisKen 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 Reanalysis Ken Peh 2014-05-28 13:56
      - Selection of samples for Incurred Sample Reanalysis Ohlbe 2014-05-28 14:27