Bioequivalence and Bioavailability Forum • An example of IS response.

An example of IS response. [Bioanalytics]

posted by Ohlbe – France, 2020-05-26 19:27 (2209 d 02:57 ago) – Posting: # 21478
Views: 17,337

Dear Shuanghe,

❝ I would make a suggestion to the CRO for the modification of their SOP to take incidence like this into consideration. One way is like you said, repeat another set of CC at the end. What else can we do to improve it?

They should read the FDA Q&A, but it does not help much here (there are some QC samples with an IS response tracking that of the subject samples).

They should also look at the special issue of Bioanalysis on this topic. It includes papers from both regulators and industry, with nice case studies. The overall conclusion is: acceptance criteria such as mean ± x% are useful, but not in all situations. Plotting the IS response to look for trends and systematic differences is a must.

Also a nice review, just published in the same journal, free access :-)

—
Regards
Ohlbe

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 ≠ required Shuanghe 2020-08-03 13:56
      - Broken-stick regression Helmut 2020-08-04 18:04