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The following message was posted to: PharmPK
Dear all,
As per the US FDA guidance for bioavailability and
bioequivalence, The MR drug product of a previously
approved IR drug product should be submitted as NDA.
and the guidance recommends the following BA studies
to be conducted for an MR drug product
1) A single-dose, fasting study on all strengths of
tablets
2) A single-dose, food-effect study on the highest
strength
3) A steady-state study on the highest strength
Suppose if the higher strengths of the drug is not for
initial therapy (i.e. If there are any adverse effects
with First high dose and dose need to be titrated for
higher strengths), How can i carryout these studies at
highest strength.
I want to know for MR products, can i get the
bio-waiver at higher strength by doing the
bioavailability studies at lower strength.
US FDA guidance for MR products says, we need to carry
out the study at higher strength and we can get the
waiver at lower strengths. But exactly opposite is
what i want.
Can any one suggests the studies to be conducted
taking these points into consideration.
Any references in this regard is highly appreciated.
Many thanks in advance,
gundu js
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The following message was posted to: PharmPK
Jaya,
What you want is not likely to happen. BE, food effect are required on
the
highest strenght for an MR product as is dose proportionality on all
strengts. If your highest strenghts is not tolerated as a single dose,
you
can negotiate to do the studies at steady-state.
Good luck!
sandra
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Hi Jaya,
If you are concerned with the safety of the subjects in studies
performed with the highest strength you should contact FDA, present
your protocols and concerns and request the change in the approach.
radu
Radu D. Pop
Director Biopharmaceutics
Pharma Medica Research Inc.
966 Pantera Drive
Mississauga, Ontario
Canada, L4W 2S1
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