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From: "David Benziger"
What is the current practice for performing carbon-14 studies in humans to
elucidate metabolism and excretion of a new drug:
Does the radiolabled synthesis need be GMP???
How much "GMP" needed for formulating an intravenous dose??
What about stability assessment?
Sample retention requirements?
Any guidance in these general areas appreciated
Dave
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From: "Tata, Prasad N"
Date: Sun, 15 Jun 2003 08:49:28 -0400
Subject: RE: PharmPK Carbon-14 studies in humans
The following message was posted to: PharmPK
Dear Dave:
In my opinion, Radio labeled compound needs to be a GMP lot. Then the fine
line comes regarding GMP for test dosing, if it is prepared, dispensed and
administered under the supervision or by a qualified person (meaning a
licensed Pharmacist or MD) then it will fall under extemporaneous dispensing
so may not need GMP, however it is strongly desired to have CGMP lot. Fine
line for the dispensing is that the injection prepared under sterile/aseptic
conditions should be administered with in seven days (remember that
dispensing Pharmacy texts in undergrad pharmacy programs?) preferably on the
same day.
In my past experience all the biological samples for ADME studies we saved
samples 6 months after completion of the sample analysis and report
completion or six months after the after the long term stability for the
biological samples whichever is convenient in the conduct of the study. If
you are taking about retention of the test article (dosage form) well it is
your call, I would recommend until you finish your NDA submission in case
you need to work on some fire fighting they come to your rescue.
Hope this helps.
Good luck.
Prasad Tata
Mallinckrodt, Inc.
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From: Bernhard.Ladstetter.-a-.merck.de
Date: Mon, 16 Jun 2003 10:00:04 +0200
Subject: Re: PharmPK Carbon-14 studies in humans
The following message was posted to: PharmPK
Dave,
best practise is to do the radiolabel synthesis non GMP but with proper
reporting of synthesis route, purity, specific radioactivity etc.
Formulation has to be done under GMP incl. stability assessment. There are
no specific sample retention requirements provided that the radioactivity
content of the samples is well documented and archived.
Regards,
Bernhard
Bernhard J. Ladstetter, Ph.D.
Head of Global Non-Clinical DMPK
Global Preclinical R&D
Institute of Drug Metabolism and Pharmacokinetics
Merck KGaA
Am Feld 32
D-85567 Grafing
Germany
Phone: +49 (0)8092-700810
Fax: +49 (0)8092-700899
e-mail: bernhard.ladstetter.-a-.merck.de
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From: "Sharp, Dale"
Date: Tue, 17 Jun 2003 07:51:02 -0400
To: david.-at-.boomer.org
Subject: RE: PharmPK Re: Carbon-14 studies in humans
The following message was posted to: PharmPK
For those of us without in-house radiosynthesis labs, are you aware of any
who manufacture radiolabeled compounds GMP? I am not.
Dale Sharp
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The following message was posted to: PharmPK
PerkinElmer offers custom synthesis services under GMP.
Satu Kovanen
Product Technology Leader, Detection Systems
Biopharmaceutical
PerkinElmer Life and Analytical Sciences
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)