Paradox of tolerance [RSABE / ABEL]

posted by Astea – Russia, 2020-12-02 00:34 (1269 d 05:03 ago) – Posting: # 22100
Views: 5,811

Dear Preachers!

You've discovered truly a very interesting feature!
But I have some doubts in logical equality of the inflation of TIE and consumer's risk. Can you please explain my faults in the following reasoning?

Suppose we expect drug A to be highly variable (in the previous study somewhere in Antarctica W. Oodendijk et al. have got CV>30% for the reference drug). Which of the following options should we prefer to write in the protocol in order to care of the customer:

a). Use pre-specified wider limits 75-133 for Cmax (no inflation?)
b). Use the GCC-GL approach (inflation up to 21%?)

Suppose that at the end of the trial we get CV≤30% and CI within 75-133, but out of 80-125.
Then for the a-approach we should conclude the drug BE, for the b-approach - fail to conclude BE.
That is the risk of the customer to get a bad product is higher in the first approach if we define "a bad product" as a non-HVD with the limits out of 80-125.
The difference is in the fact that in the first approach we proclaim the drug to be good if it is within the limits 75-133.

Until about 2013 there were a lot of studies in Russia with 75-133 limits for Cmax even for non-HVD drugs.

"Being in minority, even a minority of one, did not make you mad"

Complete thread:

UA Flag
Activity
 Admin contact
23,035 posts in 4,835 threads, 1,645 registered users;
52 visitors (0 registered, 52 guests [including 7 identified bots]).
Forum time: 06:37 CEST (Europe/Vienna)

The mediocre teacher tells.
The good teacher explains.
The superior teacher demonstrates.
The great teacher inspires.    William Arthur Ward

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