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I have small doubt ie., whether we can do the BE studies for two
formulations - one formulation is in the form of TABLET and another
one is CAPSULES form.
Whether we can proceed as like other BE Studies or what. Does it
affect DT and Dissolution.
Kindly clarify my doubts. Thanks in advance.
devisha.
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Dear Devisah
Ideally in bioequivalence studies, dosage form should be same otherwise
it is a comparative bioavailability study. However, it depends on the
objectives of the study. Should the objective is to assess the
bioequivalence, it would be considered as bioequivalence study.
Thanks
Nadeem Irfan
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Dear Devisha
I assume your formulation is an immediate release dosage form. If
this is the case, both dosage forms will disintegrate in the
stomach. Consequently, the drug dissolution will start to at the
gastric fluids. In order to have some confidence in the Bio-Study,
the comparative dissolution method in different media has to be
challenging enough to assure you that the dissolution is not the rate
limiting. Overall, this is a general thinking, the active
classification and the formulation will have great influence on the
outcome of the BE. I would like to invite more dissociation by the
group regarding this subject.
Kind Regards
Nabil
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thank you nadeem & nabil,
My drug formulaltions are immediate drug release formulations. We
would like to go for bioequivalence studies of innovator tablets of
drug formulaltions vs test capsules of drug formulations.
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Hi Deva
What is the objective of your study? Is it an ANDA filing? As far as
i know, for US ANDA filings both the Test and the RLD products have
to be tablets or capsules. I have never conducted a BE study using a
tablet against a capsule. As i have said your objective could be
different. Correct me if i am wrong.
Good Luck
Manish Issar, Ph.D
Biopharmaceutics Dept.
Sandoz Inc. (Formerly Eon Labs Inc.)
4700 Sandoz Drive
Wilson, NC-27893
USA
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You can go for the bio study for Tab Vs. Capsule, this is possible in
case where you would have file a suitability petition for change in
dosage form from Tab to Cap or a 505B(2) for a new dosage form.
However although you may prove bioequivalence of Tab VS Cap, which
you are required to, but you will not get an AB rating for your product.
Thanks
Kiran
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Dear Dr. Issar
Would you please educate me on this issue; If have tablet vs capsule,
and proved to be bioequivalent, why can't I submit ANDA?
Thank you in advance
Nabil
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Try to understand the definition of Pharmaceutical Alternative and
'Same'.
If I am correct, US ANDA can be filed for Pharmaceutical alternative
provided the innovator product has not been removed from market for the
safety and efficacy reason.
Rakesh Chaurasia
Mumbai-India
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Dear Rakesh,Nabil and Manish,
Please see section 505(j) 2(C)
enlisting the requirements and circumstances when applicant can seek
approval of "Suitability petition". There is a small area of this
section which does overlaps with one clause of section 505(b)2 but still
its very much clear there.
To clarify this issue here, ANDA for a
Pharmaceutical alternative can be filed subject to prior approval of
suitability petition which can be filed mostly for change in dosage form
and dosage strengths in comparison to RLD.Due to enactment of Pediatric
research equity act in 2003 , an applicant for filing through this route
has to get approval of suitability petition along with a granted waiver
request for pediatric studies for ANDA which is up to discretion of
agency and decision goes case by case basis.In essence, the route is
still open but slightly tricky to handle since PREA came into
force.
Pharmaceutical alternatives will not be fully substitutable to
RLD and hence will not be assigned "A" rating.
Now coming to Rakesh's point: "If I am correct, US ANDA can be filed
for Pharmaceutical
alternative provided the innovator product has not been removed from
market for the safety and efficacy reason"
Filing through
suitability petition route has nothing to do with this, It can be filed
anytime even if RLD exists in market or its withdrawn from market
voluntarily without safety and/or efficacy concerns.If RLD is withdrawn
from market for safety and efficacy reason then none of the application
whether it is 505(j) ANDA, 505(j)2(C) "suitability petition" or a
505(b)2 "paper NDA" filed or pending approval will be entertained by the
agency.
Now coming to your last point , what happens when RLD is
withdrawn from market voluntarily without any safety or efficacy
concerns. Answer is : The first generic product available that time in
market or under filing with FDA will get RLD status. ( Please see Orange
book for Fenofibrate & cefixime).
I hope this helps you,
Kind
regards,
Pradeep Bhadauria
Lead Scientist
Cardinal Health
Inc,
Pharmaceutical Development
160 ,Magellan Lab Ct,NC,USA
Phone # 919-465-8161
www.Cardinal.comPTS
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The key thing is the active priciple as long as it is the same go
ahead and do a relative biovailability test you are on the right track
s.o.o
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Dear Pradeep
You have very eloquintely captured the nittygritties of the
suitability petition as a regulatory pathyway for change from the
innovator. I would like to add to your statements of PREA as i have
some experience filing suitability petitions. To circumvent the need
for pediatric study has become the biggest challenge as on date. With
kind fo experience we have encountered with the suitability
petitions, i would strongly recommed to go with filing a 505 B(2)
application as that makes some progress with your filing although it
may be a costly process.
Chow
Kiran
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Hi Kiran,
Both Suitability petition and 505(b)2 routes have "pros
and cons" associated with it.I agree that suitability petition route is
very tricky but I have seen couple of very successful approvals with
Pediatric waiver.All you need is a good regulatory consultant and a
great deal of luck !!. Moreover,505(b)2 may not be feasible for many
products due to cost and time involved in it and you still have to do
pediatric studies as by default commitment. But if the molecule is a
potential blockbuster, 505(b)2 will be a route to explore.You might get
NDF exclusivity also.
Anyways, good luck !
Kind regards,
Pradeep
Bhadauria
Lead Scientist
Pulmonary & Nasal Drug Delivery.
Cardinal
Health Pharmaceutical Development
(A drug delivery div. of Cardinal
Health Inc.)
160, Magellan Lab
Court
Morrisville,NC,27560
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