No replies to this topic

[AmandaH]

I would like to ask some questions concerning bioequivalence studies with Madopar (Levodopa/benserazide). To the moment I can`t find any information about pharmacokinetic parameters of benserazide. Furthermore I wonder if it is necessary to measure pharmacokinetic parameters only for levodopa or for levodopa and benserazide in order to prove bioequivalence. There is limited information about it. I found only 1 trial where they had measured only levodopa. And in 1 review I saw that it is preferable to prove therapeutic equivalence in combination with bioequivalence because of differences in exipients and possible differences in amounts and quality of active ingredients which anyway can influence response of a patient I would to get a view on question how to prove equivalence of Madopar and a generic product in a proper way,