Bioequivalence and Bioavailability Forum • Placement of CC

Placement of CC [Bioanalytics]

posted by Ohlbe – France, 2020-05-26 19:32 (1867 d 20:23 ago) – Posting: # 21479
Views: 13,187

Dear Helmut,

❝ 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.

Really ? I usually see only singlets, not duplicates (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). If duplicate samples are used, it is indeed rather strange to put both at the beginning.

—
Regards
Ohlbe

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 CCOhlbe 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