Is it possible to do direct multiple dose BA-BE study of IR test Vs. IR ref. (2-way X over approach).
Any regulatory will allow to do direct multiple dose study without single dose study?
IR reference is approved for three time a day so....
Hi, multiple dose BE study should not be required for IR formulations. Why do you plan multiple dose study?
Best regards,
Piotr
Dear Sir,
Thank you.
It is true that multiple dose study is not required for IR.
But, I have Test-IR and Test-MR so I want to compare both with Reference IR. If possible then want to plan in single study.
If its possible to do study by that way then there is possibility to reduce reference group. And we can get data in single study.
Any regulatory will accept data of direct multiple dose study for IR.
Dear Sir or Madame,
Basing on limited data you provided, I would suggest that Test-IR should be compared to IR-reference in a separate, single-dose study. I would also suggest pilot single dose fasting and fed study for test-MR before you go to multiple-dose study.
Best regards,
Piotr
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