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RegisterParadox 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 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.
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"
"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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz