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The following message was posted to: PharmPK
Dear Colleagues,
Can somebody guide me on following query?
- We are planning to conduct a steady-state comparative bioavailability
study (for NDA submission). How to choose frequency of dose
administration for multiple dose steady state (SS) study? What are other
regulatory recommendations to be covered during protocol designing?
- Reference product is intended to be given twice daily, while test
product is proposed to be administered four times a day. I am not aware
of any guidance on this. Does anyone throw some light on this issue i.e.
whether FDA accept this approach?
Thanks a lot in advance for any help.
Thanks with Regards,
Prakash
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It is better to compare a sustained release to a sustained release,or
intermediate release to intermediate release.
Why don't you get a reference product which is also administered four
times a day. I'm afraid there might be no correlation in the
Biopharmaceutic parameters.
s.o.o
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