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We have a situation here: We have a 40 mg/ml pediatric suspension
(RLD: 200 mg/5 ml) of Azithromycin to be tested for bioequivalence. I
am of the opinion that if we are taking the study on adults we should
dose in usual adult dose i.e. 250 mg or 500 mg. Now as per our
analytical team, a dose of 300 mg or above should be considered since
they have to be comfortable enough to detect the same in plasma.
Again, to reduce the AE and to make the dose = 10ml, we are thinking
of dosing 400 mg instead of 500 mg. My questions:
1. can we go ahead with 400 mg dosing of test and reference in each
period of study?
2. are the kinetics linear for the drug?
3. Can we give any dose or the usual human dose (500 mg day 1, though
maintenance dose on day 2-5 is 250mg)?
I would be grateful if someone could guide me.
Dr. Gagandeep Singh
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