Bioequivalence and Bioavailability Forum

Hi BE-proff,

❝ But you give references to western guides in submitted documents they are usually accepted by Russian experts

Sorry for misunderstanding, I corrected the previous post to be in accordance with russian GL.
There are no links to the EMA/FDA GL in russian "Red Book" (I mean this chapter)
Yes, the experts accept the EMA/FDA approaches if you provide the appropriate link.
BTW did you see at least one plan of studies in accordance with EMA MR GL (for example) in Russia?
Even for MR vs. MR studies the requirements stated in the EMA GL are not satisfied. Providing the results of only one BE study performed in Russia (i.e. single dose fed or single dose fasting) is sufficient for registration purposes.