Fixed dose combination and single administration analysis [General Sta­tis­tics]

posted by Dr_Dan  – Germany, 2015-07-16 11:12 (3497 d 14:22 ago) – Posting: # 15092
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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

Kind regards and have a nice day
Dr_Dan

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