Bioequivalence and Bioavailability Forum • maybe R too?

maybe R too? [Two-Stage / GS Designs]

posted by yjlee168 – Kaohsiung, Taiwan, 2014-05-23 23:17 (4407 d 07:56 ago) – Posting: # 13001
Views: 12,848
(edited on 2014-05-24 08:35)

Dear Detlew & Helmut,

Sorry to cut in. Thank you both for the great summary of the two-stage approach. It sounds like that it is possible to implement all these using R or into bear together with PowerTOST.

❝ [...]

❝ You should get:

❝ CVintra: 0.1821 (=18.21%)

OK, the example is from WLN. CV_intra = 18.21% (for C_max?) with 12 subjects. So it is not a HVD, is it? Does EMA or FDA accept the two-stage BE if it is the case?

❝ [...]

❝ sampleN.TOST(alpha=0.0294, targetpower=0.80, theta0=0.95, CV=0.1821, design='2x2')

Nice explanations and thank you both again.

—
All the best,
-- Yung-jin Lee
bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

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 fiction Helmut 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    - outdated software; mixed vs. fixed effects Helmut 2014-07-02 10:40
      - outdated software; mixed vs. fixed effects MGR 2014-07-03 06:32