open-label BE trials maintain blindness [Study Per­for­mance]

posted by kimhuang – China, 2023-10-14 11:19 (134 d 06:38 ago) – Posting: # 23752
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How do open-label BE trials maintain blindness until the database is locked?
Holding a data review meeting before DBL to discuss whether PK parameters (such as Pre-dose concentration, Abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) are included in the analysis set (without treatment assigment) will have risk of potential unblinding?

Edit: Category changed; see also this post #1[Helmut]

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