Bioequivalence and Bioavailability Forum • Placement of CC

Placement of CC [Bioanalytics]

posted by Helmut – Vienna, Austria, 2020-05-26 19:03 (726 d 16:18 ago) – Posting: # 21481
Views: 6,858

Dear Ohlbe,

» Really ?

Really.

» I usually see only singlets, not duplicates …

That’s risky. If a calibrator at the LLOQ or ULOQ is out of range, you are in trouble.

» (in the past many labs analysed the LLOQ and ULOQ samples in duplicate, with only one of the results being used following an SOP, but all others were singlets).

I see. How does such an SOP look like? Pick out the best?

—
Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 CC Helmut 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 CCHelmut 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