Bioequivalence and Bioavailability Forum

❝ we are planning steady state study for EU submission.

what are the primary PK parameters? What are the secondary PK parameters?

FDA guidlines saying about swing. but in EMA guidlines there is no word related to swing, kindly explain what was the effect of swing parameter in PK.

Thanks and Regards.
venugopal

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we are planning to conduct a single dose study plus steady state study for EU submission.
On first day single dose profiling and will be dosed continually till 7 day OAD, again on 7 th day profiling (steady state).

In this study,
If in case single dose study 90% CI were with in BE limits, but steady state study 90 % CI were not with in BE limits, or vice versa.
then what will be final conclusion of the study.

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post!
Don’t reply to your own post; you should edit the original one within 24 hours. I merged both and deleted the second one. [Helmut]