Bioequivalence and Bioavailability Forum • PE outside {0.80, 1.25} not possible

PE outside {0.80, 1.25} not possible [Two-Stage / GS Designs]

posted by Naksh – India, 2023-12-25 12:42 (900 d 10:07 ago) – Posting: # 23807
Views: 8,423

Namaste Helmut !

Thanks for the reply and I agree that PE outside is not possible but it has been observed in pilot studies of mesalamine where many BLQs are observed in a subject which skewed the T/R to the extreme.

95% is a very bold to assume in HVD. but should actual T/R ratio for re-estimation of sample size? somehow it should be according to potvin method B?

This wonders me with T/R ratio of 85% as well.

power.RSABE(alpha = 0.0294, theta0 = 0.85, CV = 0.6978, n = 24, design = "2x2x4")

[1] 0.6369

rss(n = 24, r = 2, S_WR = 0.630, params = list(sig_level=0.0294))

$rss

[1] 21



rss(n = 24, r = 2, S_WR = 0.630, params = list(sig_level=0.0294, GMR=0.85))

$rss

[1] 100

Complete thread:

Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 11:20
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
  - Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
    - Extreme test case Helmut 2023-12-24 13:01
      - Extreme GMR Naksh 2023-12-25 04:16
        
        PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
        
        PE outside {0.80, 1.25} not possibleNaksh 2023-12-25 11:42
        
        Forget rss() Helmut 2023-12-25 13:15
        
        Forget rss() Naksh 2023-12-26 04:49
        
        TSD useful at all? Helmut 2023-12-26 12:50