Bioequivalence and Bioavailability Forum • An example of IS response. Need your helps.

An example of IS response. Need your helps. [Bioanalytics]

posted by Shuanghe – Spain, 2020-05-26 18:32 (1603 d 12:36 ago) – Posting: # 21476
Views: 9,396

Dear Sukalpa,

Many thanks for your comments.

❝ ...The criteria fulfilled because the response of IS in CC and QC increased along with study samples, as per SOP.

❝ ...

❝ But personally speaking, I have come across this type of scenarios in the past. But possibilities of the change in concentrations are less, because we determine concentrations based on the area ratio.

I don't doubt that the run fulfill certain criteria with certain nemerical values according to CRO's current SOP. What I'm not comfortable about is the fact that runs like this, with such obvious trends of response deviation, were not investigated. It's more about the studies in future instead of the past.

❝ Looking at the data, I think the response of IS and analyte increased proportionally as the QC samples are passed resulting a successful analytical run.

Well, with the above figure in fornt of me, I wouldn't say this was a seccessful run just because it pass certain numeric values defined in the current SOP. Given the example like this happened, I would rather question if the current SOP is reasonable enough.

—
All the best,
Shuanghe

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 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