Bioequivalence and Bioavailability Forum

Dear all,

According to the EU guideline, GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **, The drug substance is considered highly soluble if the highest single dose administered as immediate release formulation(s) is completely dissolved in 250 ml of buffers within the range of pH 1 – 6.8 at 37±1 °C.

Please help with the following:

1) What is considered as the highest single dose? Is it to do with the approved posology on the highest possible dose a patient might get a single occasion or is it the highest strength of the proposed MAA?

2) How different are the solubility experiments conducted for the quality part of dossier different to the 'BCS' solubility requirement.

I look forward to your reply.

Kind regards,
Tina

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Edit: Category and subject line changed. [Helmut]