Bioequivalence and Bioavailability Forum

Hi BE-proff,

"Welcome to the twilight zone!"
First of all ACK with Helmut's suggestion above.

Let's take a look to our "Red Book", p.200, chapter 3.1
"Bioequivalence studies are required."
What kind of studies? How many?
If you look at this chapter in the EMA GL, you will find the links to the specific GL.
There is no GL for MR in Russia and no published requirements!
All what I know is promising of the experts from FGBU. They should publish something, but no one knows when.
There is no way out...
Sorry, I didn't have any experience for absolutely new MR products in Russia and I don't know what kind of set of studies is enough according to the experts' requirements. BTW AFAIK there were some attempts from some companies, I don't know about consequences.