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Dear Members,
My query is related to the time of analysis of the metabolite in a 2-way
cross over Bioequivalence study for submission to the US FDA.
We are working on a product whose parent drug and its metabolite both
are
active. As recommended by the regulatory authority we have to prove the
equivalence only for the parent molecule and to analyse and submit the
data
for the metabolite for test and reference products (i.e. no need to
prove
the equivalence).
We have different bio-analytical methods for the estimation of these two
molecules; and the situation at our end warrants that we cannot analyse
both
these molecules together / simultaneously. We will have to have a lag
time
of at least 1 month between these two analyses.
We are still exploring our thoughts of analyzing the parent molecule
first,
then may be within 1-2 months we shall analyse the metabolite from the
duplicate plasma samples. We shall also establish the stability of the
subject metabolite in the actual storage conditions for the requisite
period
of time.
My query is whether this would be acceptable or would have some concerns
with the regulatory authority?
Has anybody had similar kind of experience with the US FDA submission?
All your comments are welcome.
Thanks in advance.
Best regards,
Hitesh Maheshwari
Hikma Pharmaceuticals
Amman, Jordan
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)