Bioequivalence and Bioavailability Forum • Ratio 125%

Ratio 125% [RSABE / ABEL]

posted by drsinghs – India, 2012-05-09 15:41 (5146 d 04:16 ago) – Posting: # 8545
Views: 9,919
(edited on 2012-05-09 16:31)

❝ 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.

Thanks HS for your opinion,
Ok if my study is for EMA and observed ratio for AUCt is 125% with 90% CI 110 lower and 140 upper, Can I expect 90% CI to be within 80.00-125.00% in replicate design study.

Also would really appreciate your comment on my generic query in prevoius post about differences in study results by these 2 designs.

Thanks & regards,
drsinghs

Edit: duplicate post deleted. You can edit your post within 24 h if needed [Ohlbe]

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