S×F vari­­ance: Follow­up [General Sta­tis­tics]

posted by jag009  – NJ, 2015-02-23 17:58 (3320 d 17:47 ago) – Posting: # 14489
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Angus,

That is my concern because it seems like (I have to revisit to confirm) the Wi obtained from G-Matrix is different from FDA's.

❝ Regarding the wording of the recent MP Guidance then what I see is the Guidance has many people reviewing and editing it sentence by sentence. It is confusing in the part you focus on. I think they are not real sure what position to take and they want to get the sponsors to produce data for them, so that after they have enough data then they can formulate a rational policy. As you have said yourself I do not see them failing a submission on that part of the Guidance.


So sponsors will be guinea pigs! This will be big guinea pigs!

John

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