Bioequivalence and Bioavailability Forum • QC medium: short answer

QC medium: short answer [Bioanalytics]

posted by Helmut – Vienna, Austria, 2012-10-18 18:14 (4605 d 06:23 ago) – Posting: # 9434
Views: 16,169

Merhaba Haydonat!

❝ We determine the medium QC […] 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.

Good point!

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

Don’t know. Personally I haven’t seen a deficiency letter covering this topic yet – but the new GL is in force for a short time now… I’m interested in opinions/experiences of other forum members.

Actually the geometric mean was suggested in the Arlington III conference report – but only for Ligand Binding Assays. Strange IMHO because a 4-parameter logistic function is symmetric. The geometric mean makes more sense for conventional assays, where the calibration range covers several orders of magnitude and calibrators are logarithmically spaced.

I will prepare are more detailed answer later on.

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Complete thread:

determining the QC medium haydonat 2012-10-18 00:26 [Bioanalytics]
- QC medium: short answerHelmut 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