No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 12:36 (721 d 11:19 ago) – Posting: # 20940
Views: 4,817

(edited by Beholder on 2019-12-06 13:06)

Dear ssussu!

» At this situation, should this subject's data with one period be included in the BE assessment?

No, you could not.

» Why?

Because you need comparison between T and R for each subject. This is the aim - to compare. In your case you have either T or R (I dont know exactly which drug was taken on period 2). At least, you could use Cmax value from period 2 if the subject withdraw after Cmax was reached. AUC - no way.

Best regards
Beholder

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