Bioequivalence and Bioavailability Forum

RSABE/ABEL in a TSD: Science fiction [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2014-05-24 00:39 (4410 d 21:08 ago) – Posting: # 13002
Views: 13,022

Hi Yung-jin,

❝ […] It sounds like that it is possible to implement all these using R or into bear together with PowerTOST.

Yes, why not?

❝ OK, the example is from WLN.

The example is from Potvin’s paper.

❝ CV_intra = 18.21% (for C_max?) with 12 subjects.

They didn’t state which PK metric the data covers.

❝ So it is not a HVD, isn't it?

The CV of the pooled data set (n=20) is 21.67%. So HVD is unlikely.

❝ Does EMA or FDA accept the two-stage BE if it is the case?

Hopefully only in such cases (conventional unscaled ABE). I have heard that some people already naïvely unreflecting submitted protocols in the EU with replicate designs for ABEL, believing that α_adj 0.0294 would maintain the overall risk type I ≤0.05. Crap.

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


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Science Quotes

Complete thread:

• SAS code for 2-stage design MGR 2014-05-22 07:45 [Two-Stage / GS Designs] 
  • SAS code for 2-stage design d_labes 2014-05-22 08:17
  • Phoenix/WinNonlin code Helmut 2014-05-22 12:24
    • maybe R too? yjlee168 2014-05-23 21:17
      • RSABE/ABEL in a TSD: Science fictionHelmut 2014-05-23 22:39
    • WinNonlin 5.2.1 setup MGR 2014-07-02 07:08
      • outdated software; mixed vs. fixed effects Helmut 2014-07-02 10:40
        • outdated software; mixed vs. fixed effects MGR 2014-07-03 06:32