Bioequivalence and Bioavailability Forum • criteria for the removal of standards from the regression

criteria for the removal of standards from the regression [Regulatives / Guidelines]

posted by Ohlbe – France, 2007-10-18 20:36 (6829 d 20:24 ago) – Posting: # 1217
Views: 6,246

Dear Ramesh,

❝ so is there any scientifica justification or any thumb rule for the removal of the CC standards.

❝ if not what will be criteria for the removal of standards if more than one is out of acceptnace criteria.

No precision in the FDA guideline on bioanalytical method validation.

The one thing to avoid, unless you want to run into trouble, would be to decide which CC to exclude based on the results of the QC samples.

What I usually see is that the CC with the highest deviation is excluded first, then the calibration curve is recalculated. If other CCs are still failing, the one with the highest deviation is excluded, and so on.

Your criteria should be defined in a pre-established SOP, and not on the basis of the results obtained.

Regards
Ohlbe

Complete thread:

acceptance of calibration curve Ramesh 2007-10-15 10:52
- Removal of data points from CC Helmut 2007-10-15 19:30
  - Removal of data points from CC Ramesh 2007-10-16 04:45
    - Removal of data points from CC Charl 2007-10-16 08:47
      - Arithmetics ;-) H_Rotter 2007-10-16 13:44
        
        Arithmetics ;-) Charl 2007-10-17 08:55
  - criteria for the removal of standards from the regression Ramesh 2007-10-16 05:13
    - criteria for the removal of standards from the regressionOhlbe 2007-10-18 18:36