Bioequivalence and Bioavailability Forum • Only for QCs; encouraged ≠ required

Only for QCs; encouraged ≠ required [Bioanalytics]

posted by Shuanghe – Spain, 2020-08-03 13:56 (86 d 00:05 ago) – Posting: # 21819
Views: 1,992

Hi Helmut,

» @Shuanghe: Can you send me a file (CSV preferred) by PM with this columns?
»

injection, type of sample (containing B, Q, C, U), back-calculated concentration, IS response

I will upload it to have sumfink to play with. Bland-Altman plots might be an option.

I sent 2 emails with csv and excel file, the latter has much more columns in case you needed it.

» An idea: Set limits based on the one batch of the method validation which was performed in the anticipated maximum size of a run.

Damn, that's a nice idea. I didn't thought about it during discussion with CRO about the modification of their SOP.

» If you have data of this batch, please give it as well.

Sorry, I don't have it.

—
All the best,
Shuanghe

Complete thread:

An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56
- 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 ≠ requiredShuanghe 2020-08-03 13:56
      - Broken-stick regression Helmut 2020-08-04 18:04