Bioequivalence and Bioavailability Forum • determining the QC medium

determining the QC medium [Bioanalytics]

posted by haydonat – Turkey, 2012-10-18 02:26 (4606 d 03:30 ago) – Posting: # 9431
Views: 17,897

Dear Members,

We determine the medium QC in our method validations by using the geometric mean of LLOQ and ULOQ to be in the range of concentration levels in study samples.

But in EMEA bioanalytical method validation guideline, medium QC is described to be around 50% of the calibration curve range.

Does using the geometric mean instead of the 50% of calibration curve range for calculating medium QC pose a problem during an EMEA audit?

Regards,

Haydonat

Complete thread:

determining the QC mediumhaydonat 2012-10-18 00:26 [Bioanalytics]
- QC medium: short answer Helmut 2012-10-18 16:14
  - QC medium: short answer ElMaestro 2012-10-18 16:51
- QC medium: lengthy answer Helmut 2012-10-19 15:47
  - QC medium concentration in 2014 Debbie 2014-06-10 19:42
    - ~geometric mean of range Helmut 2014-06-17 14:30
      - ~geometric mean of range nobody 2014-06-17 14:49
        
        ~geometric mean of range Helmut 2014-06-17 15:11
        
        ~geometric mean of range nobody 2014-06-17 18:26
        
        ~geometric mean of range Helmut 2014-06-18 16:07
        
        compromise ElMaestro 2014-06-18 17:43
        
        compromise Ohlbe 2014-06-18 20:00
        
        compromise Helmut 2014-06-19 01:13
        
        compromise Ohlbe 2014-06-19 11:15
        
        compromise nobody 2014-06-19 14:10