Bioequivalence and Bioavailability Forum • Inflated type I error: Not nice

Inflated type I error: Not nice [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2020-11-26 18:14 (1390 d 23:24 ago) – Posting: # 22088
Views: 7,322

Dear Detlew,

❝ ❝ Shit.

❝

❝ Why shit?

Cause it slipped through my attention for almost fifteen years… In South Africa for C_max fixed limits of 75.00–133.33% may be used (no replicate design needed).

❝ ❝ ❝ Quick and dirty captured code from power.scABEL.sds.

❝ ❝

❝ ❝ How, did you do that? That’s beyond me.

❝

❝ Stolen the code of subject data sims and scaled ABE evaluation in the working horse function .pwr.SABE.sds().

❝ Have a look into the code of the new but undocumented function power.fwl.sds() in the GitHub repository.

THX!

❝ ❝ ...And got 20.568% after eleven (!) hours.

❝ Wow! 11 hours for one number! 10⁶ sims in ca. 4-5 sec with my implementation.

Mühsam ernährt sich das Eichhörnchen.

❝ Some results with setseed=FALSE:

❝ power.fwl.sds(CV=0.3, n=40, theta0=0.8, design="2x2x4", setseed=F)

❝ 0.2045, 0.2066, 0.2047, 0.2051, 0.2082

❝ Seems we are simulating the same number :cool: .

Terrible for drugs which are not highly variable (reminds me on the FDA’s RSABE). The design is less important.

[image] ^{2-sequence 4-period (full) replicates}

[image] ^{2-sequence 3-period (full) replicates}

[image] ^{3-sequence 3-period (partial) replicates}

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 niceHelmut 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
        
        Bug? d_labes 2020-11-29 16:22
        
        “Feature” Helmut 2020-11-30 00:16
- 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 tolerance Astea 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
        
        PowerTOST 1.5-2.9000 on GitHub Helmut 2020-12-23 12:18