Bioequivalence and Bioavailability Forum

90% CI limbo [General Statistics]

posted by VStus – Poland, 2017-03-01 15:07 (3390 d 18:21 ago) – Posting: # 17116
Views: 23,590

Dear Helmut,
Dear all,

I have limited data about partial replicate trial (2x3x3) with RSABE, which I want to use to assess the feasibility of same study under EMA regulation (assuming that EU has the same Reference product as US).

Reported parameters:
Number of subjects (observations per treatment arm)
Swr estimated using PROC GLM
Point Estimate (%) from RSABE-approach
95% CI upper confidence bound

Is it feasible to try calculation of 90% CIs?

Can I apply the formula below?

90% CI = log(Point_Estimate) +/- Swr * qt(0.05, df))*100,

where:
df=2*n-3 for partial replicate (2x3x3);
df=3*n-4 for full replicate (2x2x4);

Thank you very much in advance!

Regards, VStus

Complete thread:

Confidence Interval for Transformed data Unbalanced study usfda_emea 2007-03-06 14:39
- CI for Transformed data Unbalanced study Helmut 2007-03-06 16:46
  - CI for Transformed data Unbalanced study drshiv 2007-03-06 18:49
  - CI for Transformed data Unbalanced study usfda_emea 2007-03-07 06:21
    - CI for Transformed data Unbalanced study Helmut 2007-03-07 12:04
      - CI for Transformed data Unbalanced study usfda_emea 2007-03-07 12:34
      - CI for Transformed data Unbalanced study Ohlbe 2014-07-30 15:04
        
        LSM limbo Helmut 2014-07-31 02:54
        
        LSM limbo Ohlbe 2014-07-31 09:47
        90% CI limboVStus 2017-03-01 14:07
        
        RSABE ⇒ ABEL Helmut 2017-03-03 13:34
        
        RSABE ⇒ ABEL VStus 2017-03-03 15:31
        
        s2wR != mse, FDA != EMA d_labes 2017-03-04 14:49
        
        s2wR != mse, FDA != EMA ElMaestro 2017-03-04 19:13
        
        s2wR from ISC in FDA approach d_labes 2017-03-05 12:18
        
        s2wR from ISC in FDA approach ElMaestro 2017-03-05 13:50
        
        s2wR != mse, FDA != EMA VStus 2017-03-04 21:41
        
        s2wR != mse, FDA != EMA Helmut 2017-03-06 13:40

90% CI limbo [General Sta­tis­tics]

Complete thread:

90% CI limbo [General Statistics]