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The absolute bioavailability of a 500 mg metformin hydrochloride
tablet given under fasting conditions is approximately 50-60%.
Studies using single oral doses of metformin tablets of 500 mg and
1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose
proportionality with increasing doses, which is due to decreased
absorption rather than an alteration in elimination.
How can I find the requirements of agencies/authorities around the
world about the need for bioequivalence studies with specific
dosages for generic drug registration, and if some of them accept the
extrapolation of results from a high dosage to a smaller ? In other
words, does anybody know a country where is possible to register
metformin 500 mg and 850 mg as a generic drug, presenting
bioequivalence studies with metformin 850 mg?
Tanks for the attention,
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