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Registeropen-label BE trials maintain blindness [Study Performance]
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]
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]
Complete thread:
- open-label BE trials maintain blindnesskimhuang 2023-10-14 09:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Blinded NCA Helmut 2023-10-14 10:40
- Blinded NCA kimhuang 2023-10-14 11:53
- Blinded review of PK data: History… Helmut 2023-10-15 10:26
- Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- Blinded review of PK data: History… Helmut 2023-10-15 10:26
- Blinded NCA kimhuang 2023-10-14 11:53
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
- open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
- open-label BE trials maintain blindness dshah 2023-10-17 09:25
- open-label BE trials maintain blindness kimhuang 2023-10-18 00:50
- open-label BE trials maintain blindness dshah 2023-10-17 09:25
- open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
- Blinded NCA Helmut 2023-10-14 10:40
Ing. Helmut Schütz