Bioequivalence and Bioavailability Forum • Placement of CC

Placement of CC [Bioanalytics]

posted by Helmut – Vienna, Austria, 2020-05-26 17:35 (1600 d 18:44 ago) – Posting: # 21473
Views: 9,402

Dear Ohlbe & Shuanghe,

I agree with all of your points.

❝ The calibration curve is not repeated at the end of the run, so there is no way to check what's happening at the ULOQ, where you may get linearity issues due to detector saturation or ion suppression of the analyte by the IS.

Yep. Many CROs have the CC in duplicates only at the start of the run. IMHO, that should be avoided. I prefer to have one set of singlets at the start and another at the end.

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Helmut Schütz

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Complete thread:

An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56 [Bioanalytics]
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
  - An example of IS response. Need your helps. Shuanghe 2020-05-26 16:32
  - An example of IS response. Need your helps. Ohlbe 2020-05-26 17:46
- An example of IS response. Need your helps. Ohlbe 2020-05-26 14:42
  - Placement of CCHelmut 2020-05-26 15:35
    - An example of IS response. Shuanghe 2020-05-26 16:32
      - An example of IS response. Ohlbe 2020-05-26 17:27
    - Placement of CC Ohlbe 2020-05-26 17:32
      - Placement of CC Helmut 2020-05-26 19:03
        
        Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
        
        Duplicate LLOQ and ULOQ Helmut 2020-05-27 16:30
- An example of IS response. Need your helps. ElMaestro 2020-05-26 15:44
- An example of IS response. Need your helps. ksreekanth 2020-07-06 13:37
- Trend analysis as per recent USFDA guideline dshah 2020-08-01 07:32
  - Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
    - Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
      - Deviation from the mean response Helmut 2020-08-07 13:28
    - Only for QCs; encouraged ≠ required Shuanghe 2020-08-03 13:56
      - Broken-stick regression Helmut 2020-08-04 18:04