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

Only for QCs; encouraged ≠ required [Bioanalytics]

posted by Helmut – Vienna, Austria, 2020-08-01 16:13 (1214 d 18:51 ago) – Posting: # 21816
Views: 5,375

Hi dshah,

❝ If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required.

Only for QCs and not required but encouraged (FDA page 30, ICH page 46).
However, Shuanghe’s batch passed the criteria and hence, possibly we will not see any trend of back-calculated concentrations. But of course, the shift in IS-responses is obvious.

@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. An idea: Set limits based on the one batch of the method validation which was performed in the anticipated maximum size of a run. If you have data of this batch, please give it as well.

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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 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 ≠ requiredHelmut 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