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Hi all,
I need a small clarification regarding the Dissolution Profile data for
submission of ANDA.
If I am going for biowaiver of my lower strengths, then it is necessary
that i have to perform Dissolution profile and get the f2 value.
Now my doubts re the following
1)in how many medias should i do the dissolution profile?
2)If my product is official in USP will it suffice that i do Disso
profiling only in the dissolution media mentioned in the Monograph.
Thanks and Best Regards
Meera
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The following message was posted to: PharmPK
As far as I know, one medium mentioned in USP monograph should be
enough.
Ilbeyi Agabeyoglu
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Hi,
thanks for your reply.
Can you kindly tell me when that BCS guidance for biowaiver mentioned
in fda site will hold good? Only if my drug product is not official in
the monograph?
Thanks and Best regards
Meera
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Meera,
Provided that it is a dose proportional formulation and linear dose
kinetics is known, in the compendial medium on 12 units with atleast
three time points (excluding zero and NMT one time point after 85%
cumulative dissolution). This is for IR products. ER dosage forms
(Capsules and Tablets) have different requirements.
I am not sure of the number of strengths that can be waived. It used to
be three earlier and now I believe it is one or more strengths. If
someone can confirm this aspect. I would also like some comments on
biowaiver of lower strengths in cases where Food-effect is documented.
Regards
Natrajan Kumaraperumal
Ranbaxy Pharmaceuticals Inc.,
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The following message was posted to: PharmPK
The BCS guidance talks about biowaiver in totality based on your
in-vitro dissolution plus drug's solubility/permeability. Your query
was biowaiver in particular for lower strengths based on a passing BE
study on the bio-strength. In case of non-compendial drug products,
suggest you to go ahead with a controlled correspondence to Division of
Bioequivalence, OGD with the details. Being a 505(j) application that
you talked of, in most cases FDA does come back with relevant details.
Good Luck
Natrajan Kumaraperumal
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Natarajan,
thank you so much for your reply. that's exactly what i wanted to get
clarified...
Is the BCS guidance for the Biowaiver for the all strenghts or it can
be applied for lower strengths. But one more thing, if we look the "BA
and BE for Orally administered drugs "
Guidance, Page 13, It says for that we can request for biowaiver for
the lower strengths based on the dissolution profile and BE study of
the highest strength,.
So in that case in how many medias in which i have to do my dissolution
profiling?
Thanks in advance
Meera
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