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Dear Group
I have a case of bioequivalence where the test product is a mixture
of two types of pellets, one for each active, similar to the
reference product. What is the guidance for such drug products?
Kind Regards
Nabil
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Nabil:
I am assuming that your test product is regular dosage form, i.e.,
not in a modified release form. In that case, you will need to
conduct a study (or studies depending on where you wish to make a
submission and the active ingredients involved) where you will
evaluate the bioequivalence of both the active ingredients
independent of each other. The final decision of bioequialence or
not will require that both the active ingredients pass the criteria(s).
regards
Ashish Sharma
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