Paradox of tolerance [RSABE / ABEL]

posted by Astea – Russia, 2020-12-02 00:34 (725 d 10:15 ago) – Posting: # 22100
Views: 4,081

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"

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