Bioequivalence and Bioavailability Forum • QC medium concentration in 2014

QC medium concentration in 2014 [Bioanalytics]

posted by Debbie – India, 2014-06-10 21:42 (4005 d 11:34 ago) – Posting: # 13052
Views: 14,637

Hi,

After around 2 years of effectiveness of EMA Bioanalytical Method validation guidance, what would be the present scenario for the QC medium concentration?

Whether the Arithmetic mean or Geometric mean of calibration curve range should be used for medium QC concentration?

Is the Geometric mean of calibration curve range acceptable to FDA?

Please share the experience with the regulators.

Regards,

Debbie.

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 2014Debbie 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