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Is it ever possible to obtain a BCS-based biowaiver from FDA for a BE
study, by comparing dissolution profile similarity of two different
IR formulations, one a tablet and one a capsule, (not pharmaceutical
equivalents) of a BCS Class I compound as as described in the August
2000 guidance or some other method?
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The following message was posted to: PharmPK
Have the FDA ever use the biowavers? It seems that they do not.
please, let me know your experience.
Regards
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it seems possible to obtain biowaiver based on the
BCS for different forms but the route of administration should be same,
But it has to be filed in 503 (b)2 section, not as ANDA. The data could
be supported using the available literature for the absorbtion data of
the particular drug which should be referred to the PIL of the available
drug product and, or from the literature. But both the available and
your
product should satisfy the BCS requirement and can compare the two
dosage forms. IF required the same absorbtion data can be supported with
Caco2 absorbtion data for the drug if no published absorbtion sufficient
to satisfy BCS. Some one should try out
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The following message was posted to: PharmPK
> Have the FDA ever use the biowavers? It seems that they do not.
The answer is yes.
FDA approves biowaiver. I have had the opportunity and experience,
working with FDA on a successful biowaiver. My experience was related
to a compound, which was already on the market and using for a
different indication. Let me know if you have any specific question.
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Dear Vanapalli
I had an experience of having Bio Wavier based on BCS.
There are instances where FDA proposed for BCS wavier possibility.
However this is for Generic product where PIL is exactly same as RLD.
In your case of different indication against RLD - the proposed BCS
may not
possible.
Thanx
KUM Prasad
Hyderabad
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)