Bioequivalence and Bioavailability Forum • Trend analysis as per recent USFDA guideline

Trend analysis as per recent USFDA guideline [Bioanalytics]

posted by dshah – India/United Kingdom, 2020-08-01 09:32 (962 d 00:09 ago) – Posting: # 21815
Views: 5,033

Dear All!

If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required. FDA does ask if there is upward or downward trend observed. The important point for SOP of CRO should be - allowed limit for IS response. If this not limited for that 3 subjects, then i believe CRO's practice and SOP needs to be revised.

Regards,
Dshah

Edit: Guidelines linked. [Helmut]

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 guidelinedshah 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