Bioequivalence and Bioavailability Forum

Dear Sirs,

Highly appreciate your opinion regarding below subject.

Reference with combinations:

1) In the case that the formulation is desired to be studied with two already approved active principals, with the objective of proving that the combination does not affect the absorption of any of them, and being that one of them can not be found in isolation form; is it valid to elaborate a ad-hoc tablet from the non available drug with the excipients (ingredients) of the combined formula?

2) In the case that, a formulation with both already approved active principals is wished to be studied, with the objective of proving that the combination does not affect the absorption of none of them, and being that one of them is available in isolation form, but with different excipients (ingredients) of those in the combined formula; is it valid to elaborate a ad-hoc tablet of the active principals, only with excipients from the combined formula?

Best Regards.
Akram Halabi.

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Edit: Category changed and merged with a later post. You can edit your post within 24 hours; please don't post almost the same content twice within two minutes. [Helmut]