Outlier in BE study [Study Assessment]
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?
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]
- 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