S×F vari­­ance: Follow­up [General Sta­tis­tics]

posted by jag009  – NJ, 2015-02-21 22:08 (3322 d 19:44 ago) – Posting: # 14487
Views: 36,658

Hi Angus,

I won't be seeing him until March. I will definitely ask him about this.
He took a look at the Proc Mixed G-Matrix route to get within subject T, R and I, but he didn't comment in details. He did say the #s can be obtained from that route.

I just don't like the wordings FDA stated in the draft guidance. It looks like an open ended question -> "Q2D has an allowance of 0.03". They want us to present both Q2D and 95% UBC, but the ending statement seems to indicate that they want to see Q2D no more than 0.03 rather than both Q2D and 95% UCB no more than 0.03. They need some sort of English 101 training???

John

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
84 visitors (1 registered, 83 guests [including 8 identified bots]).
Forum time: 17:53 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5