Bioequivalence and Bioavailability Forum • Replicate Design: Scaling FDA

Replicate Design: Scaling FDA [RSABE / ABEL]

posted by Ben – 2012-10-23 13:32 (4630 d 20:54 ago) – Posting: # 9446
Views: 10,487

Dear all,

While for EMA the 90% CI must fall within exp(± k*σ_WR), where k=0.760, the FDA has a different favored approach. One has to calculate the upper 95% limit of (μ_T-μ_R)² - 0.797σ_WR² and check whether it falls below 0 or not (btw, nice slides Helmut). Now, my question is whether this approach using the 95% upper limit can also be rephrased (equivalently) in an "easier" way, that is, in terms of 90% CI must fall within exp(± k*σ_WR) (using just a different k). On these slides from the FDA it seems that it is the same as scaling the acceptance range using k=0.893. Is it really equivalent?

Thanks,
Ben

Edit: Category changed. [Helmut]

Complete thread:

Replicate Design: Scaling FDABen 2012-10-23 11:32 [RSABE / ABEL]
- Maybe – but why? Helmut 2012-10-23 15:35
  - Maybe – but why? Ben 2012-10-23 16:03
    - Got it. Helmut 2012-10-23 16:23
  - FDA Mixed up d_labes 2012-10-23 16:23
    - FDA Mixed up Helmut 2012-10-23 16:34
  - Maybe – but why? Ben 2012-10-27 17:04
    - Maybe – but why? Helmut 2012-10-27 17:57
      - Maybe – but why? Ben 2012-10-28 13:57
        
        Potvin (and beyond?) Helmut 2012-10-28 15:59
        
        Potvin (and beyond?) Ben 2012-11-01 10:17