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Brazilian legislation currently does not require bioequivalence
studies for drugs that are not intended for systemic absorption.
Classical examples are mebendazole, albendazole and tiabendazole.
The point is that if those drugs have indications such as treatment
of neurocysticercosis, that implies a systemic absorption and all PK
issues. However there's currently a gap that can be exploited.
I'm collecting data on how this issue is dealt with by other
regulatory agencies such as FDA/EMEA.
If anyone has any directions on this, I'd appreciate.
Thanks in advance.
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