Bioequivalence and Bioavailability Forum • Extrapolation of Calibration Curve

Extrapolation of Calibration Curve [Bioanalytics]

posted by auditor – India, 2012-02-10 07:45 (5248 d 17:28 ago) – Posting: # 8090
Views: 9,628

Dear All,

This is something regarding the practice deference between Indian CRO and over sea's. In India we prefer to prepare calibration curve within the establish calibration curve. however in some of the over sea's data we have observed that they are some times using higher values of ULOQ then the establish one in the validation due to differences in weight taken. As a part of justification they said that till date agency has not raised any question on that as the difference is very less.

Kindly advice me on above mentioned case. is it acceptable? is regulatory accept if prepared ULOQ is slightly higher then the established during validation?

Regards,

Auditor

Complete thread:

Extrapolation of Calibration Curveauditor 2012-02-10 06:45
- Exact weight Ohlbe 2012-02-10 12:05
  - Exact weight auditor 2012-02-10 15:54
    - Exact weight: impossible Helmut 2012-02-10 17:33
    - Exact weight Ohlbe 2012-02-10 18:10
      - Exact weight Helmut 2012-02-10 19:15
        
        Exact weight auditor 2012-02-11 06:49
        
        What’s the problem? Helmut 2012-02-11 12:59
        
        What’s the problem? ElMaestro 2012-02-11 20:20
        What’s the problem? auditor 2012-02-13 05:35
        
        Adjusted dilution? Helmut 2012-02-13 13:29
        What’s the problem? Aceto81 2012-02-16 10:50
        
        What’s the problem? auditor 2012-02-16 12:23
        ±5%? Helmut 2012-02-16 13:24
        
        weight pharmino 2012-02-17 21:24
        
        API/formulation Helmut 2012-02-18 13:34