Bioequivalence and Bioavailability Forum

hi~ all

Again, I want to hear your opinion come to writting.

The drug is Carvedilol.

Development a protocol for your reference to make decisions based on what basis do you decide?

As following fasted-three data

Fast-Study (#1)

Fast-Study (#2)

Bioequivalence study of Two Different Tablet Formulation of Carvedilol in Healthy Volunteers Drug Res.55, no. 4, 212-217(2005) Fast-study (#3)

The following three kinds of data you anything, would develop a protocol based on?

And why can you tell me whether it is based? I do not care more than your own logic


My stupid another question.

Fed-Study (#1)

Fed-Study (#1) and fast-study (#1) and fast-study (#2)
They all recived the same approval by MHRA it looks like carvedilol of drug

In korea, usually first generic is fasted study
second generic is fasted study...

and then in MHRA Some tests fasted study... some tests fed study...

Can I do this only in your country? in our country, I pretty much can not do
"OTL" <== "Setback mode"

Wait for your sincere answers ^^;;

Thank you so much...

BJ

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Edit: Category changed. [Helmut]