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The following message was posted to: PharmPK
Dear Colleagues,
Input needed
A conventional release 20 mg tablet preparation
(vasodilator) is administered three times a day.
Now its sustained
delivery system has been developed having potency of
35 mg and administered twice a day.
This new formulation has shown improved C max, AUC and
less variability in blood levels without any side
effect in small trails.
What are the regulatory requirements to launch such
new product? Do we need to go for large scale trial?
Looks forward to your suggestions.
Thanks
Best regards,
Jagdish
Jagdish K Jaiswal, M.Pharm.
Research Associate
Pharmacokinetic & Drug Metabolism Laboratory
Department of Pharmacology
All India Institute of Medical sciences
New Delhi-110 029
INDIA
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The following message was posted to: PharmPK
Apparently you did a BA/BE study with the new formulation and the results
are satisfactory. Any other trial should not be necessary. In vitro
dissolution studies should suffice.
Best regards.
Ilbeyi Agabeyoglu
Fac.Pharmacy
Gazi University,
Ankara.Turkey.
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Dear Jagdish,
Potency of 35 mg or strength of 35 mg? Improved Cmax and AUC meaning =
what?
Higher levels? Equivalence? Side effects cannot be adequately evaluated =
in
small trials.....
Thus, more information is needed before this question can be adequately
answered.
Best regards,
Thomas Senderovitz, M.D.
Director Clinical Pharmacology & Kinetics
Ferring Pharmaceuticals A/S
International Center
Borups All=E9 177
DK-2400 Copenhagen NV
Denmark
Phone:
Direct: +45 38 15 04 58
Switchboard: +45 38 15 03 00
Mobile: +45 24 25 52 24
Fax: +45 38 15 03 05
E-mail: thomas.senderovitz.at.ferring.com
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The following message was posted to: PharmPK
hi!
check FDA.org for bioequivalence studies. they have
classified the drug into four categories. check which
class your drug belongs to and accordingly you could
go ahead with it.
deepak
st. johns university.
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The following message was posted to: PharmPK
Dear Jagdish,
I feel you are preparing a dosage form that necessarily reduce the
dosage frequency but the total dose daily dose is more in your
therapy that may be due to short biological halflife of your drug so
it requres more loading dose.We are concerned with Cmax at steady
state so you need to conduct bioavailability studies both single dose
and multiple dose against conventional three times daily dosage form
to demonstrate its clinical suitability.
Now for launching the product in US market you need to file a paper
NDA ( New Drug Application)for that it is a regulatory requirement to
conduct controlled clinical trials to document safety and efficacy of
new product.
As far as launching in India is concerned i can answer it only after
knowing the status of similar product in global market i.e. whether
it is availabe in international market or not. If it is entirely new
you may have to submit small clinical trial( 25 -50 patients) data
along with Bioavailability data.
I think this will suffice.
Pradeep S. Bhadauria
Scientist-II
Torrent Research Centre.
Gandhinagar, INDIA.
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