Fixed dose combination and single administration analysis [General Sta­tis­tics]

posted by jag009  – NJ, 2015-07-16 08:22 (4003 d 11:29 ago) – Posting: # 15090
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Hi,

I don't understand your reasons for #2 and #3.

You said the test is a FDC and there is no reference FDC. Therefore your reference would be to administer 2 products (R1 and R2).. #1 will work. I ran this kind of study for an NDA FDC before and there were no issues.

Thanks
John

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