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Dear All,
Kindly clarify the following doubt.
Consider that 40mg (higher strength) of the drug product 'x' is a RLD
as per Orange Book and not 20mg (lower strength). I am aware that we
can go for a BE study in the fashion, 2x20mg of Test Vs. 40mg of
Reference, if the sponsor files an ANDA for 40mg.
But, here the sponsor wants to file an ANDA with 20 mg, the lower
one. What we have to do?? Can we go for the BE study with the Non-RLD
20mg product?? Or, is it necessary to go only for the RLD 40 mg one??
Need your valuable suggestion.
Habeeb
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For Bioequivalent studies the strength for the reference and product
under study should be same.
The reference product should be of good quality. Practically it is
possible to compare 40 mg with 20 mg except for 20 mg you have to
give two tablets.
So that both for the reference and test product the strength is 40
mg. As long as the reference product is of good quality there is no
problem.
s.o.o
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The following message was posted to: PharmPK
Habeeb,
You can certainly conduct a bioequivalence study on whatever strength
you wish. Based on our interpretation of the guidances and our
experience with submitting to the FDA, you can also submit an ANDA for
the 20 strength. If you were to do this you might not be able to
request the biowaiver for the higher 40mg strength. The FDA generally
requests that a company conduct a bioequivalence study on the RDL
anticipating that there will be a biowaivier for the additional lower
strengths if the formulation is dose proportional and the drug has
linear pharmacokinetics.
The study that you proposed (Test-2x20mg vs Ref-1x40mg) does not
actually fulfill the FDA requirement. In actuality you are still only
testing the 20mg strength of the test product but using a 40mg dose.
This would not be acceptable as a 40mg strength submission.
Robert Lepage, M.Sc., CCRP
Manager, Biopharmaceutics & Assistant Study Director
Pharma Medica Research Inc.
E-mail rlepage.-a-.pharmamedica.com
www.pharmamedica.com
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