Bioequivalence and Bioavailability Forum

❝ ❝ we are planning to do bioequivalence study on Azithromycin Caps,

❝ ❝ but whether we can use this methodology 2 capsule of 250mg of test & 2 caps of 250 mg of originator which will be equivalent to 500mg.

We need 500mg Approval not 250mg whether this is acceptable as same study is been performed by Teva.

❝ Why do you want to do that? Do you want to market only the 250 mg strength? If yes, perform a study with 1×1 250 mg. Only in rare cases (problems with the sensitivity of the analytical method) your design would makes sense. I don’t think any regulator would accept such a justification for azithromycin.

We need to market 500mg only. whether this is acceptable.

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]