Bioequivalence and Bioavailability Forum • ~geometric mean of range

~geometric mean of range [Bioanalytics]

posted by Helmut – Vienna, Austria, 2014-06-17 16:30 (4386 d 05:05 ago) – Posting: # 13074
Views: 16,240

Hi Debbie,

EMA’s GL states “around 50% of the calibration curve range” and FDA’s current draft “in the midrange”…
Most colleagues I’ve talked to in recent years spike the middle QC close to \(\sqrt{LLOQ \times ULOQ}\).* That’s justified because calibrators generally follow a geometric progression. Never heard of any problems with assessors/inspectors.

Some people shift the MQC from \(\bar{x}_{geom}\) towards the closest calibrator in order to allow a direct comparison if deemed necessary. Fine with me.

—
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Helmut Schütz

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Complete thread:

determining the QC medium haydonat 2012-10-18 00:26
- 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 rangeHelmut 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