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Dear all,
To do a BE study of anti-TB FDC formulation containing
rifampin,isoniazid,pyrazinamide and ehtambutol(150,75,400,275mg) can we
select the comparator product as 3 FDC formulation containing
rifampin,isoniazid,pyrazinamide 150,75,400 (Rifater) and seperate
ethambutol formulation(myambutol).
since we have drugs in different strength and ethambutol is available
only as 400 and 100 mg tablet can we go for
4 tablets of 4FDC(test) versus 4 tablets of 3FDC+ 2 ethambutol 400 mg
tablets +3 ethambutol 100 mg tablets(Ref)
then we have to give 4 tablets during 1 period and 9 tablets during
another.is it not too much?wont we face problem in getting healthy
volunteers?
also can we go for simplified WHO protocol of sampling upto 8 hrs?will
it be ok with pyrazinamide having half life of 8-10 hrs?
is it needed to determine the metabolites concn?
is it needed to determine the drugs in urine also?
with thanks,
Muhiyideen
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The following message was posted to: PharmPK
dear mohiyideen,
why dont you take Myrin P forte(Lederle) as the
reference drug, it has the same combination as your
drug.
as for the WHO abbreviated protocol for anti TB FDCs,
i recall that the protocol is only good for checking
the BE of rifampicin component of the FDCs, but you
will have to make sure this is what only I can recall
from years back.
wajahat
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dear wajahat,
in WHO list there is no comparator FDC product for the FDCs containing
4 drugs.so i think we cant use any 4 FDC product as a comparator
unless and until we have complte clinical study details on 4 FDCs.
please clarify
regards,
Muhiyideen
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