Fixed dose combination and single administration analysis [General Statistics]
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
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
Complete thread:
- Fixed dose combination and single administration analysis BRN 2015-07-15 10:21 [General Statistics]
- Fixed dose combination and single administration analysisjag009 2015-07-16 06:22
- Fixed dose combination and single administration analysis BRN 2015-07-16 11:23
- Fixed dose combination and single administration analysis Dr_Dan 2015-07-16 09:12
- Fixed dose combination and single administration analysisjag009 2015-07-16 06:22