Bioequivalence and Bioavailability Forum

Freedom to some degree [🇷 for BE/BA]

posted by yjlee168  – Kaohsiung, Taiwan, 2009-04-21 16:03 (5850 d 23:11 ago) – Posting: # 3575
Views: 68,368

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]

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