Bioequivalence and Bioavailability Forum

Missing samples [Study Assessment]

posted by ElMaestro – Denmark, 2020-04-29 19:21 (1721 d 09:34 ago) – Posting: # 21367
Views: 5,346

Hi Amira Gouda,

❝ he did not attend the samples collection for 24,48 and 72 hours intervals (as the study protocol stated that the hospitalization lasts only for 12 hours)

BE is generally done on the PP population, not on the ITT.
This guy is clearly not participating PP, his AUC is not outright a meaningful indicator of product performance, so out he goes, I think.

—
Pass or fail!
ElMaestro

Complete thread:

Outlier in BE study Amira Gouda 2020-04-28 15:36 [Study Assessment]
- Outlier in BE study mittyri 2020-04-29 11:50
- Outlier in BE study Ohlbe 2020-04-29 15:19
  - Outlier in BE study Amira Gouda 2020-04-29 16:35
    - Missing samples Ohlbe 2020-04-29 17:02
      - Missing samples Amira Gouda 2020-04-29 17:08
        
        Missing samplesElMaestro 2020-04-29 17:21
        
        Missing samples Amira Gouda 2020-05-01 23:50
        
        Options Helmut 2020-05-02 11:35
        
        Options Amira Gouda 2020-05-03 21:15

Missing samples [Study As­sess­ment]

Complete thread:

Missing samples [Study Assessment]