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21/10/02
Dear Dr. David / Dr.Edward O'Connor,
My excipient is solublizing various lipophillic drugs and we would like
to
register the same in USFDA as it has not been explored as an excipient
in
USA for the administration through I.M. I.V. route.
Kindly let us know what are the toxicological tests ( GRAS?) in animal
models required to be carried out for its approval in USFDA.
We await your kind guidance in this regard.
My email address is : kurani.-a-.themismedicare.com
With regards,
S. P. Kurani
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You would use the approach of testing your excipient as if it were the
drug
itself. That would include/should include repro tox. If it is similar
to
another agent you could examine the testing profile for that agent. for
example PEG400
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Dear Mr.Kurani,
The process of developing of new excipients and submission thereof to
get the status of GRAS in USFDA IIG is a resource intensive work and
may be as costly as the development of the NCEs.It is important to
perform risk-benefit assessments on proposed new excipients in drug
products and to establish permissible and safe limits for these
compounds. Safety data should be submitted to support use of new
excipients.
However ,the burden of the extensive toxicological studies required may
be reduced substantially if u are exploring its use for paricular route
wherein the data is not established ( as it seems to be ur case).In
such circumstances partly you can make use of the published data
avialble in public domain and make the reference to it.If the data
exists for ur excipient in human use by anyother route then this will
waive you to do many or in some cases virtually all non clinical
studies normally required and what u need to establish is the limited
dose levels and safety of the said excipient by intended route only.
Please note that you may be asked by FDA to submit pharmacokinetic
profile for excipients if it is extensively absorbed or biotransformed
( as u said its a lipidic and it will require it). It will become
imperative to substantiate the available data with additional studies
like ADME if it is the case with ur excipient.
Best way you can refer approval of Cyclodextrins wherein an extensive
studies were asked by FDA.
Please also note that many other issues like BSE/TSE qualification
would be required if ur excipient is of natural( animal) origin.
You may further refer the following guidance document by USFDA:
http://www.fda.gov/cder/guidance/3812dft.pdf
I hope this would of help to you.
Kind regards,
Pradeep S. Bhadauria
Research Scientist
Ranbaxy Research Laboratories
INDIA.
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