Outlier in BE study [Study As­sess­ment]

posted by Ohlbe – France, 2020-04-29 15:19 (98 d 20:28 ago) – Posting: # 21362
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Dear Amira,

» a BE study of standard design with truncated AUC 0-72, certain subject in one phase completed the samples up to 72 hours (test product) while in the other phase completed up to 12 hours (Reference product)

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 ?

In the first case: this would provide grounds for excluding them from the stats (should be pre-specified in the protocol). In the second case: you're in trouble.

Regards
Ohlbe

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