Bioequivalence and Bioavailability Forum

s2wR != mse, FDA != EMA [General Statistics]

posted by d_labes – Berlin, Germany, 2017-03-04 15:49 (2602 d 11:09 ago) – Posting: # 17132
Views: 17,708

Dear Helmut, dear VStus,

I assume that the s2wR you have (or swR) is the intra-subject variance estimated with R data.
If this is the case the elaborate answer by Helmut is only valid if s2wR is equal to the MSE from the evaluation of all data, which is necessary for calculation of the point estimate and 90% CI of T versus R.

But s2wR = MSE is not necessarily true in all cases, although it is in many cases a reasonable assumption.

Moreover the FDA evaluation uses intra-subject constrasts to evaluate s2wR an µT-µR including the 90%CI whereas the EMA recommended method is bases on common ANOVA (aka GLM in SAS speak. Both evaluation methods give different results. Usually slight differences, but ...

Thus my answer to the question "Is it feasible to try calculation of 90% CIs?" for the EMA based on the results of a FDA evaluation is a clear No.

What you get by Helmuts calculations is only an approximate solution which may be good enough but may also terrible fail.

—
Regards,

Detlew

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 limbo VStus 2017-03-01 14:07
        
        RSABE ⇒ ABEL Helmut 2017-03-03 13:34
        
        RSABE ⇒ ABEL VStus 2017-03-03 15:31
        
        s2wR != mse, FDA != EMAd_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

s2wR != mse, FDA != EMA [General Sta­tis­tics]

Complete thread:

s2wR != mse, FDA != EMA [General Statistics]