Freedom to some degree [R for BE/BA]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2009-04-21 14:03 (4565 d 11:58 ago) – Posting: # 3575
Views: 64,473

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 v2.9.0:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here

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