predefine in the Protocol whenever possible [PK / PD]

posted by mittyri – Russia, 2022-05-15 00:21 (764 d 06:37 ago) – Posting: # 22987
Views: 1,504

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

Complete thread:

UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
127 visitors (0 registered, 127 guests [including 82 identified bots]).
Forum time: 06:59 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5