Outlier in BE study [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-04-29 16:35 (141 d 23:21 ago) – Posting: # 21364
Views: 2,169

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]

Complete thread:

Activity
 Admin contact
21,068 posts in 4,392 threads, 1,463 registered users;
online 16 (0 registered, 16 guests [including 11 identified bots]).
Forum time: Friday 15:57 CEST (Europe/Vienna)

The great enemy of the truth is very often not the lie–
deliberate, contrived and dishonest—but the myth—
persistent, persuasive and unrealistic.    John F. Kennedy

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5