Bioequivalence and Bioavailability Forum

Hi All...

At present i am working on XYZ molecule at three different strengths 10 mg, 25 mg and 50 mg for EU submission.

Currently only RLD available is for 25 mg. A couple of years back we performed a pilot biostudy and proved that 10 mg tablets show linear PK and dose proportionality with 25 x 2 dose (two 25 mg tablets administered). But their linear PK data is not available in the public domain.

Now since only 25 mg RLD is available, can i opt the following options to perform biostudy for getting approval for all three strengths:

1. 10 mg x 2 and half tablets vs 25 mg RLD
   
2. 10 mg x 5 tablets vs 25 x 2 mg RLD
   
3. 25 mg x 2 tablets vs 25 x 2 mg RLD
   
4. 25 mg vs 25 mg RLD

Is is there any other option that i can market all the three strengths.

Regards,

Prashant

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Edit: Subject line and category changed. [Helmut]