S×F vari­­ance [General Sta­tis­tics]

posted by jag009  – NJ, 2014-12-24 17:21 (3381 d 18:46 ago) – Posting: # 14165
Views: 40,441

Hi Angus,

Of course the Concerta BE studies will not be RSABE based since the SwRs are all less than 0.294. So for partial AUCs + Cmax we will go through the ABE routine and conclude based on 80-125% CI. Then Helmut's suggestion above can be used to evaluate the 2nd criteria. The 2nd criteria (seems to me) is IBE/PBE based and I have no clue if you can get the info from the ABE routine. Personally I just don't see how one can fail the 2nd criteria (in my thinking) but then you have to demonstrate both... The 95% UCB I believe is for FDA to collect data, they probably want it for their own use.

Hope I answered your question.

P.S. I still don't understand the email you got from Ana regarding the computation of S2D from the G Matrix. If I recall correctly, she said to use the between subject variances of T & R + the between subject covariance for T & R???? See post :confused:

Happy Holidays!

John

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