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The following message was posted to: PharmPK
Dear all,
We would like to conduct a BE study for one drug in fasting
and fed conditions. The test product to be used for both the
studies is from same batch but the reference product is from
different batches for both the studies. According to me this
should be OK. However I would like to hear your valuable
comments.
Regards,
Dr Suhas
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The following message was posted to: PharmPK
Dear suhas
Usually, the products should be from the same batch. While, it is more
compliant to federal regulations (and hence avoids FDA query), it also
makes sense as it will avoid any error that may be due to differences
(mostly dissolution variation) between products from different
lots/batches.
While chances of such variation are low, it is not rare, in which
case it
may give false results for you formulations' bioequivalence. Use of same
batch removes error due to this factor.
However, you can use the product from different batches and there are
pretty good chance that there is little/no variation between the two.
You
may establish dissolution similarity in various dissolution media as a
supporting evidence.
Regards
Rajesh
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The following message was posted to: PharmPK
Dear Dr Suhash,
There is no problem in conducting fasting and fed study with
different batches of the Reference product,but the reference should
not differ in any aspect except the batch Numbers. Further you have
to retained two reference sample used for the two different studies.
Regards
Manoj KV
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Dear Suhas,
For the BE studies conducted for ANDA submission you should use the same
lot of test and reference products for both fasting and fed studies.
This
is what FDA recommends as per the Guidelines "Food-Effect
Bioavailability
and Fed Bioequivalence Studies".
With Regards,
V.Radhakrishna
Clinical Pharmacology and Pharmacokinetics
Tel:-09247250924
Ext:-3287
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Dear Suhas
I suggest not to use reference product (or test product) of different
batches in the pivotal studies. Because 2 batches will differ in
actual drug content, and one will find lot of difficulties in
intepretation of results. In some cases you may have to repeat a set
of studies !!
(The decision will also depend on questions that you would like to
ask in different studies.)
Regards,
Vinay
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Dear Suhas,
regarding the batch no. of different product for innovator drug is
very long procedure to demonstrate the all raw data.
for pivotal and pilot study USFDA is very clear only for ref and test
drug assay should meet only 5% variation of assay limit.
in addition with rearding the retain samples you have to store at
your facility for both batch no. which you said.
now decision is on you whether you go for study with different batch
or not.
as per my understanding to go with the study by two different batch
no. is not problem with regulatory aspect.
paresh mistry
Accutest, Ahmdedabad
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dear suhas
I thing its better to use the reference product from the same batch.
if its not possible you need to assure the % purity and RS of the
different batches.
i hope this helps for you. thank you.
A.karthik
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