## Paradox of tolerance [RSABE / ABEL]

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 C

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 C

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 C

_{max}(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 C

_{max}even for non-HVD drugs.—

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

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

### Complete thread:

- Inflated type I error with fixed widened limits? Helmut 2020-11-25 10:50 [RSABE / ABEL]
- Inflated type I error with fixed widened limits? d_labes 2020-11-25 15:07
- Inflated type I error with fixed widened limits? Helmut 2020-11-26 00:09
- Inflated type I error with fixed widened limits d_labes 2020-11-26 15:38
- Inflated type I error: Not nice Helmut 2020-11-26 17:14
- Power of the GCC framework and power of PowerTOST d_labes 2020-11-28 11:20
- Sample sizes (ignoring the inflated TIE) Helmut 2020-11-29 11:21

- Power of the GCC framework and power of PowerTOST d_labes 2020-11-28 11:20

- Inflated type I error: Not nice Helmut 2020-11-26 17:14

- Inflated type I error with fixed widened limits d_labes 2020-11-26 15:38

- Inflated type I error with fixed widened limits? Helmut 2020-11-26 00:09
- Inflated type I error with fixed widened limits? wienui 2020-11-29 14:03
- Inflated type I error with fixed widened limits d_labes 2020-11-29 17:51
- Inflated type I error with fixed widened limits Helmut 2020-11-30 00:14
- Inflated type I error with fixed widened limits wienui 2020-11-30 03:30
- Houston, we have a problem! Helmut 2020-11-30 14:42
- Paradox of toleranceAstea 2020-12-01 23:34
- Οὐτοπεία ∨ Εὐτοπεία Helmut 2020-12-02 01:37
- Uchronia Astea 2020-12-02 09:46
- Steampunk Helmut 2020-12-02 11:34
- Dieselpunk Astea 2020-12-02 15:28
- Dieselpunk Helmut 2020-12-02 16:18

- Steampunk? OT d_labes 2020-12-02 19:30
- Steampunk? OT Astea 2020-12-02 19:58

- Dieselpunk Astea 2020-12-02 15:28

- Steampunk Helmut 2020-12-02 11:34

- Uchronia Astea 2020-12-02 09:46

- Οὐτοπεία ∨ Εὐτοπεία Helmut 2020-12-02 01:37

- Paradox of toleranceAstea 2020-12-01 23:34
- PowerTOST 1.5-2.9000 on GitHub Helmut 2020-12-23 12:18

- Houston, we have a problem! Helmut 2020-11-30 14:42

- Inflated type I error with fixed widened limits wienui 2020-11-30 03:30

- Inflated type I error with fixed widened limits Helmut 2020-11-30 00:14

- Inflated type I error with fixed widened limits d_labes 2020-11-29 17:51

- Inflated type I error with fixed widened limits? d_labes 2020-11-25 15:07