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Hello to all:
I am anticipating a request to perform an in vivo ADME study using a
14C-labeled drug. I am interested in literature references/general
information sources on the design and conduct of such studies. Some obvious
issues include estimation of the radiochemical dose (Ci of label to be given
to a rat), safety (Is CO2 a problem?), sampling techniques (plasma, urine,
feces) and pitfalls (effect of 14C label location on drug molecule, isotope
effects etc.). Any help is welcome.
Richard Knapp
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[Two replies - db]
Date: Mon, 14 Feb 2000 05:12:23 -0500
From: efoconnor
X-Accept-Language: en
To: PharmPK.at.boomer.org
Subject: Re: 14C In Vivo Studies
examine the structure oi the drug. is it likely to be cleaved or to have
additonal molecules added? are there easily re,ovable methyl, mehtyl amino
groups prresetnt. can tou use deuterated compounds instead? these,
with the new
software available in LC mass spec instruments PE biosystems can give very good
traceability and compound identification wo concersn of duplication of
effort/dup of staff/ prep room etc. they are not as sensitivie but. edoc
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From: "medical"
To:
Subject: Re: PharmPK 14C In Vivo Studies
Date: Mon, 14 Feb 2000 17:37:29 +0530
X-Priority: 3
Dear sir,
I would suggest you got hru Roland and Tozer,,Priciples of
clinical Pharmacokinetics.
Regards,
Dr. Amit Taneja
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Richard,
Your questions pretty much ranged over two file cabinets and 6 feet of
bookshelves. However, here are a couple of pointers:
1. As for calculating the radiochemical dose (material requirements and
specific activity) download a free copy of DOSECALC from my web site at
http://www.SummitPK.com (select the Free Tools page).
2. One of the best sources for monographs, bulletins and articles on the
various aspects of conducting radiolabelled metabolism studies is the LSC
manufactures. Both Packard and Beckman have a history of highly useful
documents. And the older information is still part of current practice, so
don't be put off by a pre-1990 date. One example: "Liquid Scintillation
Analysis - Science and Technology", M. Kessler, ed, (1989) Packard Inst.
Co., Meriden, CT
Hope this helps a bit. Email me directly with any specific questions.
Regards,
David
David S. Farrier, Ph.D.
Summit Research Services
1374 Hillcrest Drive
Ashland, OH 44805 USA
Tel/Fax: (419)-289-9207
Email: DFarrier.aaa.SummitPK.com
Web Site: www.SummitPK.com
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Hello to all,
We are looking for a clinical site with experience in conducting human
metabolism/mass balance study, either in Canada or in the US.
Any suggestions ?
Regards,
Corinne Campanella
Pharmacokineticist
Clinical Pharmacology
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[Two replies - db]
From: Makoto Niwa
Date: Fri, 3 Mar 2000 20:26:43 +0900
To: PharmPK.at.boomer.org
Subject: Re: PharmPK 14C In Vivo Studies
Dear Corinne:
I know a CRO "Innapharma" in NJ, USA conducted human
14C-balance/metabolism study (although they seem to have
no web sites). I hope this might help.
Makoto Niwa, M.Sci.
Nippon Kayaku Co., Ltd.
e-mail:mniwa.-at-.nipponkayaku.gr.jp
URL:http://member.nifty.ne.jp/mniwa/
Tokyo, Japan
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Date: Fri, 3 Mar 2000 19:11:27 -0800 (PST)
From: Garry Boswell
Subject: Re: PharmPK 14C In Vivo Studies
To: PharmPK.at.boomer.org
MDS Harris is a CRO that has conducted many such
studies. They can be contacted at 402-437-4770.
Garry Boswell
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