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Hi all
I am a student learning about pharmacokinetics, for both animal and
clinical research. Does anyone have suggestions for learning tools,
books, courses, conferences etc. that I could explore to further my
education? This would be greatly appreciated!
Betty Lawrence
Resolution Pharmaceuticals Inc.
Mississauga, Ontario, Canada
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[Two more replies - db]
From: "Mr. E"
To:
Subject: Re: PharmPK Educational Information
Date: Wed, 21 Apr 1999 21:08:37 -0400
X-Priority: 3
Dear Ms. Lawrence...
The FDA will have data on quality systems and compliance for pharmPK and
clinical trials.
Go to : www.fda.gov then go to the Drug division...might want to check
biologics, too, in case
your work involves biologics.
Be well....
Arthur
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X-Sender: jelliffe.-at-.hsc.usc.edu
Date: Thu, 22 Apr 1999 12:10:23 -0700
To: PharmPK.at.pharm.cpb.uokhsc.edu
From: Roger Jelliffe
Subject: Re: PharmPK Re: Educational Information
Mime-Version: 1.0
Dear Judith Walker:
I share your pain that you only get a few hours to teach basic PK
to Med
students. The important thing, I think, is to teach them WHY this is
important, so that they can use good and capable clinically oriented
software to let them hit a target goal, selected individually for each
patient, with the greatest possible precision. They will not get this from
AUC, Cl, V, etc. alone. I would be most happy to talk further with you
about this.
Sincerely,
Roger Jelliffe
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I agree with Roger. I cant see the point of teaching med (or pharmacy)
students about how to calculate AUC. This is never needed for *typical* use of
PK in clinical practice. What is needed is a sound understanding of what CL
and V are and how they can be used to predict dose in an individual. Then how
to interpret sparse conc measurements ("TDM") to estimate individual CL and V.
The best way to do that is with "good and capable clinically oriented software
to let them hit a target goal" but some simple "back of the envelope" methods
can also be applied in many situations e.g. by using a conc sampled in the
middle of the dosing interval as a measurement of the average steady state
conc and thus being able to calculate CL from dose rate/Css.
--
Nick Holford, Dept Pharmacology & Clinical Pharmacology
University of Auckland, Private Bag 92019, Auckland, New Zealand
email:n.holford.aaa.auckland.ac.nz tel:+64(9)373-7599x6730 fax:373-7556
http://www.phm.auckland.ac.nz/Staff/NHolford/nholford.html
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[Two replies - db]
X-Sender: dkisor.-at-.postoffice.onu.edu
Date: Mon, 26 Apr 1999 08:31:16 -0500
To: PharmPK.aaa.pharm.cpb.uokhsc.edu
From: "Kisor, David"
Subject: Re: PharmPK Re: Educational Information
Mime-Version: 1.0
A distinction should be made here between noncompartmental AUC (one of the
trapezoidal approaches) and compartmental modeling that can also be used to
calculate an AUC. I agree with others that the noncompartmental AUC is not
something commonly applied in the clinical setting. Using software to
attain a target goal is the approach to be used. Some of the software
packages do provide an estimate of the AUC (compartmental approach;
Bayesian estimation). As an example. with "Once daily aminoglycosides"
there is some suggestion to target an AUC for dosing (Br J Clin Pharmac
1995;39:605-609), however, clinically the data available wil not allow a
noncompartmental approach.
The only reason I see for mentioning the noncompartmental (trapezoidal) AUC
approach is that, currently, many initial PK papers are published using
noncompartmental appraoches. This is done mainly because that approach was
used in drug development and presented to many regulatory agencies, and the
reports can be put into manuscript form and published. Since these papers
are "out there", we should make physicians and pharmacacists aware of the
approaches, so they can understand these papers. This is not to say that
alot of time should be spent on these approaches. Just make the student
familiar with what is done and the limitations. We spend 10 to 15 minutes
(out of 50 hours) on this in our PK course.
---
X-Lotus-FromDomain: WATSON
From: nsingh.at.watsonpharm.com
To: PharmPK.-a-.pharm.cpb.uokhsc.edu
Date: Mon, 26 Apr 1999 07:41:24 -0700
Subject: Re: PharmPK Re: Educational Information
MIME-Version: 1.0
With due to respect to Prof. Holford, I would like to point out that AUC as a
pharmacokinetic metric still plays a pivotal role in drug discovery and
development. As an exposure parameter, no other metric has been so heavily
relied upon as AUC in quantifying toxicity, efficacy and equivalency. I did
not want the above point to be lost in the debate with respect to TDM.
Regards
N. Singh
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[Two replies - db]
X-Sender: jodrell.at.icrf.icnet.uk
Date: Tue, 27 Apr 1999 08:22:07 +0100
To: PharmPK.aaa.pharm.cpb.uokhsc.edu
From: Duncan Jodrell
Subject: Re: PharmPK Re: Educational Information
Mime-Version: 1.0
I would also like to reply to these comments - in oncology AUC is often an
important parameter relating to outcome of therapy and for carboplatin (a
widely used cytotoxic), a "target" AUC is administered routinely to
patients. Therefore, a knowledge of AUC is very important and an
appreciation of how it might be derived is also important.
I suspect that Dr Holfords comments may relate to the detailed calculation
of a trapeziodal AUC and this may indeed not be necessary, but please do
not undervalue the importance of AUC in certain settings.
Duncan Jodrell
***************************************************************
Duncan I. Jodrell DM, MSc, FRCP (Edin.),
Deputy Director, ICRF Medical Oncology Unit,
University of Edinburgh, Western General Hospital,
Edinburgh, EH4 2XU.
jodrell.-a-.icrf.icnet.uk
Tel: 0131 467 8447
Fax: 0131 332 8494
***************************************************************
---
Date: Tue, 27 Apr 1999 21:30:34 -0400
From: Brennan
MIME-Version: 1.0
To: PharmPK.aaa.pharm.cpb.uokhsc.edu
Subject: Re: PharmPK Re: Educational Information
I'm inclined to favor the practical over the theoretical myself. AUC is
interesting but having analysed levels on a few hundred patients, I've
never had
the need to know the AUC. Good modeling programs however are very useful,
especially when data points can be conserved and incorporated into the model.
For clinical purposes, the software needs to be fast, clear and accurate. The
rest is up to the clinician doing the analysis.
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Please contact jurger venitz at venitz.aaa.hsc.vcu.edu. He has an excel lotus
and Qp program for the paramteres and more..
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