Bioequivalence and Bioavailability Forum • QC sample levels in each run

QC sample levels in each run [Bioanalytics]

posted by Ladi – Thailand, 2015-09-17 15:58 (3581 d 23:21 ago) – Posting: # 15421
Views: 7,460

Dear Ohlbe,

❝ "the upper limit of the acceptance range (750 + 15 %) is 862 ng/ml, which is above your ULOQ. You will certainly get some results above 800 ng/ml, but as you are not supposed to extrapolate above the ULOQ you won't know whether they pass or fail. Your HQC concentration should not be above 695 ng/ml (upper acceptance limit 799 ng/ml)."

So when the EMA-BMV guideline says:

"the LLOQ, within three times the LLOQ (low QC), around 30-50% of the calibration curve range (medium QC), and at least at 75% of the upper calibration curve range (high QC). The mean concentration should be within 15% of the nominal values for the QC samples,"

what it actually means is HQC should be 75-85% of ULOQ. Right?

Regards,
Ladi

Complete thread:

QC sample levels in each run TK 2015-09-15 12:22 [Bioanalytics]
- QC sample levels in each run Ohlbe 2015-09-15 12:54
- QC sample levels in each run TK 2015-09-17 05:01
  - QC sample levels in each run Ohlbe 2015-09-17 10:35
    - QC sample levels in each runLadi 2015-09-17 13:58
      - Concentration of HQC Ohlbe 2015-09-17 14:48
  - QC sample levels in each run TK 2015-09-21 04:57