Bioequivalence and Bioavailability Forum • Standard calibration curve

Standard calibration curve [Bioanalytics]

posted by Ken Peh – Malaysia, 2014-01-13 18:20 (4154 d 04:02 ago) – Posting: # 12162
Views: 12,049

Dear Members,

In EMEA Guideline on bioanalytical method validation, under 4.1.4 Standard Calibration Curve, it is written that "The back calculated concentrations of the calibration standards should be within ±15% of the nominal value, except for the LLOQ for which it should be within ±20%"

My questions are as below:

Besides the accuracy values, is regression coefficient value important, eg. R square >0.99 ? Should both be considered as acceptance criteria? The accuracy and R square values.
If we have 8 calibrators, from back calculated concentration of the calibration standards, we found 2 calibration standards failed accuracy. One of calibration standard was LLOQ. To keep the LLOQ, instead of dropping the failed LLOQ, reject another calibration standard which passes the accuracy and reevaluate the calibration curve. As a result, 7 calibration standards pass. Is this the right approach ??
On what occasion weighting method is allowed ? Weighting method is not mentioned in EMEA guideline but in FDA new draft guideline.

Highly appreciate your kind comments.

Thank you.

Regards,
Ken

Complete thread:

Standard calibration curveKen Peh 2014-01-13 17:20 [Bioanalytics]
- Standard calibration curve Ohlbe 2014-01-13 21:50
  - Use of weighting factor Ken Peh 2014-01-14 16:37
    - Confusing table Helmut 2014-01-14 17:32
      - Confusing table Ken Peh 2014-01-15 04:06
        
        Weights Helmut 2014-01-15 13:46
        
        Weights Ken Peh 2014-01-18 05:46
- Standard calibration curve ElMaestro 2014-01-14 10:14
  - Standard calibration curve Roberto 2014-02-18 13:27
    - Standard calibration curve Ohlbe 2014-02-18 14:53
      - Standard calibration curve Roberto 2014-02-18 17:00
- Standard calibration curve AngusMcLean 2014-03-01 01:27