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hi,
I have some doubt.
If i am making new formulation of old drug ie for example
conventional dosage to controlled release doasge form.
after making the formulation,whether we can go for the BE studies
(comparing with marketed control release of the same molecule) or
this formulation is considered as new drug. because If i want to
make new formulatlion i may using new excipients to make the
formulations.
Give me the details.
thanks in advance.
devisha
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Devisha,
DCGI>>>
You will have to compare with available SR/ CR formultion available
in the market, or compare it with Conventional release formulations
taking per day dosing in to concentration
HIren
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ramesh,
thanks for your kind suggestion. My doubt if we make a new
formulation ourself as a academic project, in that case how to go for
it. is it consider as new drug or what.
Because after making the formulations we are not going for
toxicological studies. and directly going for BE studies with human
volunteers and without going for preclinical is it advisable or
what. Here the logic is the API is known to everyone so people are
preferring to go for directly going for BE studies after doing any
controlled release formulation. Is is it ok?
devisha
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Dear All
If you have a marketed SR/CR dosage form, I would compare my new SR/
CR formulation to the old one. If you do not have a SR/CR dosage
form to compare your new formulation in a BE study, you most likely
have to compare your new SR/CR dosage form to an IR one at steady state.
The question I would like to ask is that, if I am developing a SR/CR
for an immediate release dosage form of the same active, what other
studies in addition to BE I will have to conduct to prove efficacy
and safety?
Regards
Nabil
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YOU will have to carry out toxicological studies specially sub acute.
You will have to check the food effect also on the rate and extent of
absorption of the drug.
HIren
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Hi Devisha/Hiren,
It appears from your mail that you are trying to
make CR formulations of a drug already approved for human use.I also
assume here that route of adminstration for both products remain the
same. Here there are two situations:
1. CR form is already available
in market then your application will be elligible for section 505(j) and
you can compare your CR product with availble marketed CR product and
conclude the bioequivalency.
2.If only IR product is approved and you
are trying to make a new CR product of approved drug for some
therapeutic benefits then your new dosage form ( NDF)will qualify for
section 505(b) 2 ( and full NDA also) and you need to compare your new
product with marketed IR product. Efficacy of the new dosage form
developed by you needs to be established based on limited clinical
trials in addition to comparative bioavailability studies.You will need
to establish effect of food on PK parameters to justify the
administration regime and dose proportionality if you have multiple
strengths.For safety assessment of your product you can rely on safety
data of innovator submitted to agency as a apart of NDA data package or
you can have right of reference based on published information.In short,
there will not be any toxicity studies required as long as you dosage
regime doesn't cross the daily maximum recommended dose and your drug
does not have a
narrow therapeutic index and your route of adminstration
is not changed .
As your development work is solely for academic
interest, I believe few comparative bioavailability studies will be good
enough to justify the rationale of new CR formulations.However, for
commercial product development for submission you have to follow above
mentioned requirements case by case basis.
Regards,
Pradeep
Bhadauria
Product Development
Sandoz Inc. ( a Novartis
Company)
4700,Sandoz drive.
Wilson,NC,27893,USA.
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Dear Pradeep,
Please tell me if I want to go for regulatory submission of SR
product for the first in the market..but IR is approveed then
single dose fast and fed study
MUltiple dose(steady state) fed and fast study.
and a clinical trial for efficasy...
anything else is required?
reagrds
HIren
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The following message was posted to: PharmPK
I have recently sent a question about need for bioequivalence studies
for
vitamins. Now I am sending the same inquire with more information.
In order to register generic drug there is a must to conduct
bioequivalence
study. We have lipofilic form of hydrosolubile vitamins B1 and B6,
prepared
to enhance absorption process. Generally speaking, are there any
suggestions
about bioeqvivalence studies? In EMEA guidance there is not written
anything
about omitting this investigation. Only Health Canada says that it is
not a
must for vitamins. Can we implement biowaver and perform only in vitro
dissolution testing?
Can anybody help with this issue?
Regards,
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hello sir
This is a new lipophilic water soluble vitamins. you are the first
innovator for this lipophilic vitamins or already is there in market.
if its there you need do BE studies otherwise you need to consult FDA.
A.karthik
DMPK LAB,DISCOVERY RESEARCH
DR REDDYS LABORATORIES LTD
MIYAPUR
HYDERABAD
500049
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