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RegisterFixed dose combination and single administration analysis [General Statistics]
Dear BRN,
As you explained you have a fixed dose combination (FDC) product which does not have an original reference. So bioequivalence with the reference products R1 and R2 in combination (R=R1+R2) is only one aspect. The other question you Need to answer is: How do you know that this combination is reasonable from a PK point of view? Therefore you have to conduct additionally a drug-drug-interaction (DDI)study.
BE: single dose 2x2 design T vs. R1+R2
DDI: multiple dose R1, R2, R1+R2
I hope this helps.
Kind regards
Dr_Dan
As you explained you have a fixed dose combination (FDC) product which does not have an original reference. So bioequivalence with the reference products R1 and R2 in combination (R=R1+R2) is only one aspect. The other question you Need to answer is: How do you know that this combination is reasonable from a PK point of view? Therefore you have to conduct additionally a drug-drug-interaction (DDI)study.
BE: single dose 2x2 design T vs. R1+R2
DDI: multiple dose R1, R2, R1+R2
I hope this helps.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Fixed dose combination and single administration analysis BRN 2015-07-15 10:21 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fixed dose combination and single administration analysis jag009 2015-07-16 06:22
- Fixed dose combination and single administration analysis BRN 2015-07-16 11:23
- Fixed dose combination and single administration analysisDr_Dan 2015-07-16 09:12
- Fixed dose combination and single administration analysis jag009 2015-07-16 06:22
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