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Dear Sirs,
We are developing two new drugs one for diabetes and other for
hypertension. We are interested to know pre/clinical guidelines for
evaluation of both the drugs. can any one sugest?
R. C. Gupta
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You can check the Center for Drug Evaluation and Research's (CDER)
website (www.cder.fda.gov)for the appropriate guidances or contact the
appropriate division at CDER for guidance on the pre/clinical evaluation
of these drugs (Division of Cardio-Renal Drug Products, HFD-110 for the
antihypertensive agent and the Division Endocrine and Metabolic Drug
Products, HFD-510 for the anti-diabetic agent). These divisions will be
happy to help you with your development plans.
Emmanuel O. Fadiran, Ph.D.
Senior Clinical Pharmacology & Biopharmaceutics Reviewer
OCPB, CDER, FDA.
(e-mail- fadirane.-at-.cder.fda.gov)
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Dr. Gupta,
There are several useful guidelines on the FDA web site. They address many of
the pre-clinical studies generally required for development of new compounds.
Mores specific issues should be discussed with the FDA prior to initiating the
study.
Regards,
Garry Boswell
MDS Harris
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[Two replies - db]
Sender: acy62.at.pop.dial.pipex.com
Subject: Re: PharmPK pre/clinical guidelines for evaluation
Date: Tue, 27 Apr 99 08:49:13 +0100
x-sender: acy62.aaa.pop.dial.pipex.com
From: Andrew Sutton
To: "Pharm PK",
"Multiple recipients of PharmPK - Sent by"
Mime-Version: 1.0
Dr Gupta,
For an exhaustive list of guidelines that you can download try The
European Technical Office for Medicinal Products at
http://www.eudra.org/emea/cpmp_g/cpmp_g.html.
It sounds as though you could start with guideline CPMP/ICH/302/95 Note
for Preclinical Safety evaluation of Biotechnology-Derived Products.
But there's no substitute for talking to someone who has actually run
preclinical studies of the kind you will need because target tissues for
antidiabetic drugs will differ according to their mechanism of action,
for one thing. I do know of some good consultants who would not charge
you very much at all for preliminary advice. Their knowledge of the
market for these studies would probably save you their fee many times
over anyway. Let me know if you would like a name or two
Good luck
Andrew Sutton
Andrew Sutton
ASutton.aaa.gcpl.co.uk
Guildford Clinical Pharmacology
Telephone +44 (0) 1483 406886
---
From: RH06442.-a-.rh.dk
X-Lotus-FromDomain: INTRANOTES
To: PharmPK.aaa.pharm.cpb.uokhsc.edu
Date: Tue, 27 Apr 1999 13:31:19 +0200
Subject: Ang.: PharmPK pre/clinical guidelines for evaluation
Mime-Version: 1.0
Dear RC Gupta,
This is indeed a big question. How can one develop drugs without
having guidelines at all?
You are, I guess, familiar with the ICH/GCP guidelines? As well as all
the other necessary guidelines for drug development (such as the
guidelines on statistical analysis etc.?)
Well, it depends on your market. If you have the US market in mind, I
suggest you contact FDA (see www.fda.gov). If you think about the
European market, guidelines can be found at EMEA's homepage:
www.eudra.org.
The is a specific guideline for the clinical evaluation of
antihypertensive drugs (CPMP/EWP/238/95 Revision 1 ), see
http://www.eudra.org/humandocs/humans/ewp.htm
Regards,
Thomas Senderovitz
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