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[Also check http://www.boomer.org/pkin/soft.html and the PharmPK archives - db]
Hi folks,
We are looking into obtaining software to do PK and PD Modeling for
our pharmacokinetic studies. Typically we are studying single dose
kinetics with about 16 to 20 samples per subject profile. We are
primarily interested in predicting dose ranges for future
dose-response studies. So far we have been looking into WinNonLin
from Pharsight.
Are there other products out there that we should be evaluating? Is
there a standard in the industry that is used for submissions to the
FDA?
Thanks for your thoughts,
Claire
Claire Daugherty
Manager Biometrics
Anesta Corp
cdaugherty.at.anesta.com
Phone: 801-401-7520
Fax: 801-321-7490
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[A few replies - db]
X-Sender: mentor.-a-.hardlink.com
Date: Thu, 24 Feb 2000 04:52:01 -0500
To: PharmPK.at.boomer.org
From: Daro Gross
Subject: Re: PharmPK PK/PD Modeling Software
There is no standard yet. I know because I was approached to offer the
automated screening software tools for the FDA. For the moment the tools
are not packaged for sale and are only available as a consulting service,
but you can always contact me if you need any pointers as to the features
required from an off-the-shelf package. If your study requires any
non-standard analytical tools, those can be identified as well.
Daro Gross
Analytics International LLP
maildrop.-at-.iname.com
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X-Sender: jhzwafri.aaa.merle.acns.nwu.edu (Unverified)
Date: Thu, 24 Feb 2000 10:59:55 -0600
To: PharmPK.aaa.boomer.org
From: zhao wang
Subject: Re: PharmPK PK/PD Modeling Software
SAAM II (Simulating , Analyzing And Modeling) by Resource Facility
for Kinetic Analysis (RFKA) is the most powerful tool for individual
PK analysis and I could help if you need. To get this software you
can call 206-685-2009. To contact with me, call 312-908-9710 or
e-mail: z-wang.at.nwu.edu
Zhao Wang, M.D
Northwestern University
Medical School
Anesthesia Research
z-wang.aaa.nwu.edu
---
X-Sender: jelliffe.at.hsc.usc.edu
Date: Thu, 24 Feb 2000 09:48:34 -0800
To: PharmPK.-a-.boomer.org
From: Roger Jelliffe
Subject: Re: PharmPK PK/PD Modeling Software
Dear Claire:
You might consider using the USC*PACK colection of programs.
They do both
parametric and nonparametric population modeling, and also have routines
for developing, monitoring, and adjusting dosage regimens to achieve
selected target goals, both in the central and in the peripheral, nonserum,
compartment if desired. They have been around since 1973, and have grown
over the years. As far as I know, people at the FDA tell me they do not
support any standard, but look at the science of what is done.
The really important thing, it seems to me, is to make
population models
that are optimally suited for the most intelligent action that will be
taken based on the population raw data. Usually this means developing the
optimal dosage regimen to achiebe a desired target goal, using the
population model as the Bayesian prior.
If you, or anyone else, should wish, I can send you more
information on
why we think optimal population modeling consists of:
1. Accurately calibrating the assay error pattern over its entire working
range, then
2. Using a pareametric method such as an iterative Bayesian one (which we
use) or NONMEM, to capture the remaining intraindividual variability.
3. Then, with this information, we favor using a nonparametric population
modeling approach such as our NPEM software developed by Alan Schumitzky
(or Alain Mallet's NPML) to really get what actually are the most likely
parameter distributions available from the raw population data set. You can
also examine relationships between parameters and descriptors (covariates).
The FDA has accepted several analyses using this basic approach. The
nonparametric parameter distributions are the most likely ones given the
population data, as they are not limited by prior assumptions (normal,
lognormal, etc.) about their shape. The shape of the distributions is
determined only by the raw data itself. There is more information on our
web site (especially look at technical reports and publications). Let me
know and I will send you, or anyone else who wishes it, more information in
other attachments.
Very best regards,
Roger Jelliffe
Roger W. Jelliffe, M.D. Professor of Medicine, USC
USC Laboratory of Applied Pharmacokinetics
2250 Alcazar St, Los Angeles CA 90033, USA
Phone (323)442-1300, fax (323)442-1302, email= jelliffe.-at-.hsc.usc.edu
Our web site= http://www.usc.edu/hsc/lab_apk
********************************************************************
---
From: "Brian E. Davies"
To:
Subject: Re: PharmPK PK/PD Modeling Software
Date: Thu, 24 Feb 2000 17:55:33 -0500
X-Priority: 3
Claire
The other recognized program, and in my opinion a better program, is
Kinetica. You can find details and a download version at www.innaphase.com.
regards
Brian Davies
Advanced Biomedical Research
Princeton, NJ 08540
609-514-4422
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)