Bioequivalence and Bioavailability Forum • Freedom to some degree

Freedom to some degree [🇷 for BE/BA]

posted by yjlee168 – Kaohsiung, Taiwan, 2009-04-21 16:03 (5902 d 04:48 ago) – Posting: # 3575
Views: 69,198

dear D. Labes,

❝ My questions remains:

❝ Do I do something wrong here? If yes, what?

I don't know why you used TYPE=UN in your SAS code. In the FDA 2001 Guidance (Appendix E, p.37), it says: "...In the Random statement, TYPE=FA0(2) could possibly be replaced by TYPE=CSH. This guidance recommends that TYPE=UN not be used, as it could result in an invalid (i.e., not nonnegative definite) estimated covariance matrix..."

❝ If not, what are the chances that regulators accept the bear / R handling of replicate studies?

As long as bear complies with the FDA Guidance (2001) and is statistically correct, it should be acceptable, I guess. :-)

Edit: Link corrected for FDA's new site. [Helmut]

—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

Freedom for replicate bears d_labes 2009-04-17 12:06
- Freedom for replicate bears ElMaestro 2009-04-17 14:50
  - Contain does not contain d_labes 2009-04-17 15:07
- Freedom for replicate bears ElMaestro 2009-04-18 03:45
  - Freedom incompatible with baseball bats d_labes 2009-04-20 08:42
- Freedom for replicate bears yjlee168 2009-04-19 21:38
  - Freedom to some degree d_labes 2009-04-20 08:30
    - Freedom to some degreeyjlee168 2009-04-21 14:03
      - FDA loves replicate bears? d_labes 2009-04-21 16:11
        
        Cholesky factor ?! Helmut 2009-04-22 00:46
        
        Cholesky factor ?! d_labes 2009-04-22 11:20
        
        FDA loves replicate bears? yjlee168 2009-04-23 08:08
        
        FDA loves SAS code? d_labes 2009-04-23 09:48
        
        FDA loves SAS code? definitely. yjlee168 2009-04-23 10:46
        
        SAS? or R? or what? d_labes 2009-04-23 15:07
        
        SAS? or R? or what? Helmut 2009-04-23 15:25
        
        SAS? or R? or what? d_labes 2009-04-23 16:06
        
        SAS? or R? or what? Helmut 2009-04-23 16:30
        
        SAS? YES; R? why not? as long as they are useful... yjlee168 2009-04-23 19:56
        
        New Forum-Category 'bear'? Helmut 2009-04-23 20:03
        
        New Forum-Category 'bear'? yjlee168 2009-04-23 20:19
        
        New Forum-Category 'R for BE/BA' Helmut 2009-04-23 20:37
        
        New Forum-Category 'R for BE/BA' yjlee168 2009-04-24 09:19
        
        Replicated again d_labes 2009-04-24 08:27
        
        Replicated again yjlee168 2009-04-24 09:26
- getting decimals ElMaestro 2010-06-03 05:21
  - getting decimals yjlee168 2010-06-03 08:37
    - getting decimals ElMaestro 2010-06-04 01:59
- Freedom for replicate bears ElMaestro 2011-01-27 21:50
  - lmer vs. lme d_labes 2011-01-28 09:02
    - lmer vs. lme ElMaestro 2011-01-28 09:42
      - lmer vs. lme d_labes 2011-01-28 11:37
        
        V ElMaestro 2011-01-28 12:14
        
        V corrected d_labes 2011-01-28 14:12
        
        V corrected ElMaestro 2011-01-28 15:20
        
        Peculiar partial replicate d_labes 2011-01-28 16:10