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US require the bioequivalence study for generic applications to be done
with the RLD in the orange book.
Now we are having two strengths [viz. 500mg and 750mg] for a modified
release formulation, which are not dose proportional. Now the orange
book specifies only 750mg formulation as RLD. Can we justify the
biowaivers on the lower strength [even if it is not dose proportional]
by doing the fasted state and the fed state study with the RLD strength
i.e. 750mg only or need we do BE study with 500mg as well. if yes shall
only a fasted study on 500mg suffice or both the studies [fasted as
well as fed] shall be needed for 500mg?
In that case what shall be the reference drug for 500mg strength.
Torrent pharmaceuticals limited
Dear AshokBack to the Top
If your MR formulations are not proportionately similar then a request
for the biowaiver would be highly irrelevent.You would have to do
Bioequivalence on both the strengths.For lower strength 500mg consider
innovator product as refernce drug although it may not be assigned as
RLD status for the simple reason : a generic equivalent cannot be
seeked for a generic version of drug by agency.
RANBAXY RESEARCH LABORATORIES.
Kaushal,Back to the Top
I recommend you refer to the FDA guidance on BE study requirements for
ER products. It spells out the requirements reasonably clearly.
Jatin Shah, Ph.D.
Tel: 908 756 0211
Fax: 908 756 0264
Dear kaushal,Back to the Top
Bio studies for the lower strength are not required.
You can match the dissolution of both the strengths with that of the
innovator in media with pH ranging from 1.2 to 6.8.
RRL , Gurgaon
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I agree that the biowaivers are irrelevant for formulations which are
not dose proportional. however, if we are doing a fasted as well as a
fed state studies on our highest strength i.e. 750mg [as recommended
for any modified release formulation], I wonder if only a fasted state
study on the 500mg formulation shall be sufficient or shall we need to
do a fed state as well.
Dear Kaushal,Back to the Top
All I can say is that you can possibly have a justification for not
doing Fed BE studies for lower strength. It is advisable to have
conversation with FDA and negotiate with them as decisoon in such cases
goes case by case basis.
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