Bioequivalence and Bioavailability Forum • ODA for replicate designs

ODA for replicate designs - "EMA crippled model"? [🇷 for BE/BA]

posted by mittyri – Russia, 2015-08-27 12:20 (3488 d 20:14 ago) – Posting: # 15355
Views: 12,481

Dear Yung-jin, Dear Detlew,

You're absolutely right, most regulations are'nt allowed to exclude data on statistical reasons alone.

I explored forum some time ago searching the solution for "EMA Crippled model" (possible solutions for outliers detection during CVwr estimation according to the EMA GL and Q&A).
Very lengthy posts are here, here and here
BTW I didn't find the exact solution for R. Could you please enlighten me?

Yung-jin, it would be great to implement CVwr estimation in Bear according to the European requirements for replicate designs.

—
Kind regards,
Mittyri

Complete thread:

can't get information about outliers detection jerry 2015-08-26 08:37 [🇷 for BE/BA]
- ODA in bear yjlee168 2015-08-26 08:53
  - ODA in bear jerry 2015-08-26 16:00
    - ODA in bear yjlee168 2015-08-26 17:40
      - ODA in bear jerry 2015-08-26 17:58
      - ODA for replicate designs d_labes 2015-08-27 08:12
        
        ODA for replicate designs yjlee168 2015-08-27 08:51
        
        ODA for replicate designs d_labes 2015-08-27 09:17
        
        ODA for replicate designs yjlee168 2015-08-27 09:30
        
        ODA for replicate designs - "EMA crippled model"?mittyri 2015-08-27 10:20
        
        ODA for replicate designs - "EMA crippled model"? d_labes 2015-08-27 10:53
        
        ODA for replicate designs - "EMA crippled model"? mittyri 2015-08-27 11:00
        
        "EMA crippled model" - CVwR estimation and ODA in R d_labes 2015-08-27 13:17