Bioequivalence and Bioavailability Forum • Ratio 125%

Ratio 125% [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2012-05-09 15:05 (5146 d 05:49 ago) – Posting: # 8543
Views: 10,050

Dear drsinghs!

❝ To be more precise I will share a hypothetical case - if 2 waycrossver study is already completed and observed T/R ratio is 115 for Cmax and 125 for AUCt with > 30% intraCV for Cmax and > 45% for AUCt, Can I expect successful results if I go for replicate design?

Setting different regulatory requirements aside (EMA scaling allowed for C_max only, different statistical models for FDA and EMA) in all regulations the T/R ratio has to be within 80.00–125.00%. If your ratio for AUC in the 2×2 cross-over was already 125% your chance to get a ratio ≤125% is only 50% at any given sample size.

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

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Complete thread:

Full replicate design PTM139 2012-05-03 06:01 [RSABE / ABEL]
- Full replicate design Dr_Dan 2012-05-03 15:14
  - Full replicate design PTM139 2012-05-03 16:35
    - HVDs/HVDPs: tricky business! Helmut 2012-05-03 16:58
      - HVDs/HVDPs: tricky business! PTM139 2012-05-05 07:16
      - HVDs/HVDPs: tricky business! drsinghs 2012-05-09 12:33
        
        Ratio 125%Helmut 2012-05-09 13:05
        
        Ratio 125% drsinghs 2012-05-09 13:41
        
        Ratio 125%: reformulate Ohlbe 2012-05-09 16:40
        
        Ratio 125%: reformulate drsinghs 2012-05-10 05:49
        
        HVDs/HVDPs: tricky business! ElMaestro 2012-05-09 15:00
        
        HVDs/HVDPs: tricky business! drsinghs 2012-05-10 05:43