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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
active. As recommended by the regulatory authority we have to prove the
equivalence only for the parent molecule and to analyse and submit the
for the metabolite for test and reference products (i.e. no need to
We have different bio-analytical methods for the estimation of these two
molecules; and the situation at our end warrants that we cannot analyse
these molecules together / simultaneously. We will have to have a lag
of at least 1 month between these two analyses.
We are still exploring our thoughts of analyzing the parent molecule
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
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.
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