No way! But... [Design Issues]

posted by Beholder  – Russia, 2019-12-06 13:36 (1152 d 16:46 ago) – Posting: # 20940
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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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