Outlier in BE study [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-04-29 16:35 (267 d 05:58 ago) – Posting: # 21364
Views: 2,380

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:
  1. 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?
  2. I will need supportive data from guidelines for this issue specifically, could you please help me if there is?
  3. 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]

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