Bioequivalence and Bioavailability Forum

Outlier in BE study [Study Assessment]

posted by Amira Gouda – Egypt, 2020-04-29 18:35 (1595 d 01:01 ago) – Posting: # 21364
Views: 4,705

Dear Ohlbe

Thanks for your reply

❝ Do you mean to say that these subjects did not have any sample collected later than 12 hours, or that their concentration was BLQ after 12 hours ?

ِActually, the first case is our case the subject did not have any sample collected later than 12 hours which occurred in phase 1 (and he consumed reference product),
our protocol stated that dropouts and withdrawals will be included in pk, not statistics.
the subject had completed the 2 phases due to sample size issues also the product half-life is a wide range, not a definite number.
we analyzed all samples, but now:

if we exclude the subject and when submitting the study to RA, is this exclusion will be not accepted as the results of statistics including him is highly different?
I will need supportive data from guidelines for this issue specifically, could you please help me if there is?
Is re-dosing/re-testing of the subject with controls, could be supportive in this situation?

Thanks

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

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 studyAmira Gouda 2020-04-29 16:35
    - Missing samples Ohlbe 2020-04-29 17:02
      - Missing samples Amira Gouda 2020-04-29 17:08
        
        Missing samples ElMaestro 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

Outlier in BE study [Study As­sess­ment]

Complete thread:

Outlier in BE study [Study Assessment]