predefine in the Protocol whenever possible [PK / PD]

posted by mittyri – Russia, 2022-05-15 00:21 (707 d 16:29 ago) – Posting: # 22987
Views: 1,224

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%'?

Kind regards,
Mittyri

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