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Registerpredefine in the Protocol whenever possible [PK / PD]
Dear Loky do,
all predefined decision trees will point out the quality of your Protocols. The expert could clearly see during review that you did not want to cherry pick or use some unexpected posthoc findings.
I am just guessing about AUClast - if the coverage is supposed to be initially not so good (residual area > 20%), are the experts OK with that? Aren't they requesting in your jurisdiction to follow the rule '> 80% of residual areas should be less than 20%'?
all predefined decision trees will point out the quality of your Protocols. The expert could clearly see during review that you did not want to cherry pick or use some unexpected posthoc findings.
I am just guessing about AUClast - if the coverage is supposed to be initially not so good (residual area > 20%), are the experts OK with that? Aren't they requesting in your jurisdiction to follow the rule '> 80% of residual areas should be less than 20%'?
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- PK parameters Loky do 2022-05-11 15:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK parameters dshah 2022-05-12 11:42
- predefine in the Protocol whenever possiblemittyri 2022-05-14 22:21
Ing. Helmut Schütz