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The following message was posted to: PharmPK
Dear All
We are planning to perform a bioequivalence study of sustained release (as
pellet ) 100 mg sodium diclofenac capsule. Our standard, reference sample is
a generic 100 mg capsule from another company that has been approved. Is
there any valid standard 100 mg capsule or must 100 mg SR tablets be used?
Yours,
Sima Sadray, Ph D
Tehran University of Medical Sciences
School of Pharmacy
sadrai.-at-.sina.tums.ac.ir
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From: Sanjay Patel
Date: Thu, 11 Oct 2001 09:02:05 -0700 (PDT)
To: david.-at-.boomer.org
Subject: Re: PharmPK About bioavailibility of sustained release
diclofenac capsule
The following message was posted to: PharmPK
go to www.fda.gov/cder/approval and click on letter
"D" and find out which diclofenac SR is standard.
may be that will be useful.
Sanjay Patel
---
From: Edmond Edwards
Date: Thu, 11 Oct 2001 14:16:35 -0400
To: david.at.boomer.org
Subject: RE: PharmPK About bioavailibility of sustained release
diclofenac capsule
Hello Sadry,
If you're planning to market the drug in the US you MUST use the
reference drug that is listed in the ORANGE BOOK (so-called because
the original binder was orange). For the Canadian market use the
Brand name in the CPS. For the European market the Brand name drug
in the BNF is your best bet.
There's no point doing a bioequivalence study with the wrong reference.
Good Luck,
... Edmond B. Edwards, Ph.D.
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