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[Try http://www.boomer.org/pkin/soft.html - db]
The following message was posted to: PharmPK
dear friends,
Is there any software that is free to download from the net foe the pk/pd data
analysis.
Is there anyh service from any lab available for the analysis of the data.
Kindly send the webaddresses,
KolePrashant,
BITS,Pilani,
India,
Email:plkole.aaa.bits-pilani.ac.in
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The following message was posted to: PharmPK
I think you can visit boomer.org and download boomer.You can do a lot of
things using that.
Rahul
[ :-) - db]
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The following message was posted to: PharmPK
Prashant: One software which should interest you is Kinetica2000.
If I understand right, it is available free for people in the
academia. You could contact the company at www.innaphase.com
Ashish
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The following message was posted to: PharmPK
Please don' t overlook the industry standard WinNonlin from
www.Pharsight.com
Scott Handlon
Shandlon.at.pharsight.com
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Dear Colleagues:
I had thought the original question related to free software.
The ADAPT collection of Dave D'Argenio is the best free research
software I know. If one would consider other software, one might also
think of our USC*PACK PK/PD software, available since 1973, which
can be easily used for both parametric and nonparametric population
PK/PD modeling, AND for clinical patient care, which is what it is
really all about, after all. Check our web site below for more info
if interested.
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.-a-.hsc.usc.edu
Our web site= http://www.usc.edu/hsc/lab_apk
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The following message was posted to: PharmPK
Dear Colleagues,
InnaPhase is happy to announce we are continuing to provide
academic/non-profit
based researchers with a free copy of Kinetica 2000, a powerful and easy to
learn tool for non-compartmental analysis and advanced PK/PD modeling.
We are also looking forward to continuing our academic/non-profit program
with
the next release of Kinetica near the middle of the year, which will add
support
for population pharmacokinetics using our unique EM minimization approach.
We are very excited about building the global community of Kinetica users,
and are looking forward to your feedback. We will send out periodic surveys
in order to add new functionality to the program, and will soon be setting
up areas on our Internet site to allow users to share calculation methods
and new approaches they have developed with the Kinetica system.
Please contact us at sales.-a-.innaphase.com to receive Kinetica.
Best Regards,
Dan Hirshout
InnaPhase Corporation
1700 Race Street.
Philadelphia, PA. 19103
Tel : 215-299-7400 x.235
Fax: 215-299-1242
dhirshout.-a-.innaphase.com
http://www.innaphase.com
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The following message was posted to: PharmPK
Kole,
The demo (available from out web site) boast that the equations are free
(also available), but you have to buy the software to run them. Try out PK
SOLUTIONS for easy, interactive, and comprehensive pharmacokinetic
analysis at:
http://www.SummitPK.com/
Regards,
David
David S. Farrier, Ph.D. Phone: 970-249-1389
Summit Research Services Fax:: 970-249-1360
68911 Open Field Dr. Email: DFarrier.-a-.SummitPK.com
Montrose, CO 81401 Web: http://www.SummitPK.com
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The following message was posted to: PharmPK
I'm new to clinical trials and PK/PD analyses so please bear with me...
We have been using PPharm to estimate EMax and ED50 for our dose
response skin studies, partly, I have been told, because the FDA
recommends it and accepts analyses using it as part of ANDA
applications.
I have been informed by Innaphase that they are no longer supporting
PPharm, and I received a package yesterday containing Kinetica 4.0.
Does anyone know the FDA position on this product or where I can find
any FDA references to it?
Also, I am performing analyses for Bioavailability and Bioequivalence
studies, and I have an undergrad degree in chemistry and a master's
degree in statistics, but no education or training in PK/PD. Can anyone
recommend a good book reference? Online courses? Professional courses?
Valerie K. Balavage
Novum PRS, Inc.
5900 Penn Ave.
Pittsburgh, Pa. 15206
Phone: 412-363-3300 EXT. 555
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[Four replies - for books see http://www.boomer.org/pkin/book.html
and software see http://www.boomer.org/pkin/soft.html - db]
From: "Nabil B. Darwazeh"
Date: Fri, 16 Nov 2001 14:44:17 -0500
To: david.-at-.boomer.org
Subject: PharmPK Re: PK/PD software
The following message was posted to: PharmPK
You may start with
1) Applied Biopharmaceutics and Pharmacokinetics, Eds, leon Shargel
and Andrew B.C.Yu., Publisher: Appleton-Century-Crofts/NY this an old
edition. I Know there is newer one.
and
2) Pharmacokinetic and pharmacodynamic data analysis, Concept and
Applicationj, Ed: Johan Gabrielsson and Daniel Weiner
---
From: Roger Jelliffe
Date: Fri, 16 Nov 2001 11:44:38 -0800
To: david.aaa.boomer.org
Subject: Re: PharmPK Re: PK/PD software
Dear Dr. Balvage:
You might consider using the population modeling programs in
the USC*PACK collection. You can easily make and store a structural
model for Michaelis-Menten kinetics, or any other structural model
you wish. You can do this using the BOXES program to make and store
the specific structural model you want to use. You can then use a
program for doing the analyses on your PC, or a cluster of 3 Dell
machines you can access over our web site, or the full cluster of the
Cray T3E via the web site at the San Diego Supercomputer Center,
depending on your needs and wishes.
The FDA knows our work and has accepted it in several
analyses. Their position is that they do not specify any specific
software packages, only that they have good science to support them.
Our phone number is 323-442-1300. Call me any time and we can
talk more. Also, more information, including cost, is available over
our web site.
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: "Simon Davis"
Date: Fri, 16 Nov 2001 20:14:11 -0000
To: david.-a-.boomer.org
Subject: PharmPK Re: PK/PD software
The following message was posted to: PharmPK
Dear Dr Balvage,
I have just noticed your questions and will try to go some way
towards reassuring you.
Firstly I do not believe the FDA "recommends" PK analysis
products or for that matter statistical applications or your operating
environment; as a regulatory body it can indicate that it is happy to
accept analysis performed by certain applications or data transfer in
defined file formats. You are indeed correct that one of the FDA
guidelines reference PPharm but I am not sure they would consider this a
recommendation since there are several competing commercial products and
also programs developed internally by pharmaceutical companies or
universities that pharmacokinetic scientists use for their analysis and
presumably submissions. In short I would anticipate no issues with the
use of Kinetica for ANDA applications to the FDA.
More specifically, when InnaPhase developed Kinetica 4 they
incorporated several features including the algorithm from PPharm.
Furthermore extensive internal testing was preformed to compare the two
products before release of Kinetica 4. I shall enquire as to whether
these results could be made available to you should you wish to examine
them for yourself. The decision to withdraw PPharm was not taken
lightly and I hope you will find many enhancements in Kinetica to the
features you used in PPharm. InnaPhase support for our legacy products
will indeed be phased out as we transfer our existing customers to
Kinetica, however should you have a specific PPharm question we shall
endeavour to respond with a suitable solution.
As regards training in PK/PD there are many excellent courses
available - several are advertised on this mail list; similarly there
are numerous good textbooks. InnaPhase also runs training courses which
cover not just the principles but also how to use Kinetica more
effectively and efficiently. These courses can be run at your own site
or if you prefer you can attend one of our public training sessions; the
next US course will be at our head office in Philadelphia.
I hope this provides some of the information regarding Kinetica
you were seeking; I shall let some of the more experienced contributors
make their own recommendations on texts and courses. Please do not
hesitate to contact either myself or one of my colleagues at
support.aaa.innaphase.com if you should require any further assistance and
hope that you continue to use InnaPhase's software solutions.
Best regards,
Simon.
Simon A A Davis, B.Sc.
European Technical Support Scientist
InnaPhase Limited UK
Deacon House
St Mary's Court, Amersham
Buckinghamshire, HP7 0UT
United Kingdom
Cell phone : +44 7980 832 666
Telephone : +44 1494 582 080
Facsimile : +44 1494 582 454
---
From: "Gobburu, Jogarao V"
Date: Fri, 16 Nov 2001 18:26:51 -0500
To: david.-at-.boomer.org
Subject: RE: PharmPK Re: PK/PD software
The following message was posted to: PharmPK
Dear Valerie,
These are my personal views:
1. To the best of my knowledge, FDA has no preference as far as the
software is concerned.
Sound results from any software are acceptable. So, the FDA's position
is neutral.
ANDA's are handled by the Office of Generic Drugs, I encourage you to
consult with them
for any further information.
2. A good place to start learning PKPD is:
Pharmacokinetics. 2nd edition. Gibaldi M, Perrier D. (Marcel Dekker)
1982.
Regards,
Joga Gobburu,
Pharmacometrics,
CDER, FDA
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The following message was posted to: PharmPK
Dear Dr Balvage,
I have just noticed your questions and will try to go some way
towards reassuring you.
Firstly I do not believe the FDA "recommends" PK analysis
products or for that matter statistical applications or your operating
environment; as a regulatory body it can indicate that it is happy to
accept analysis performed by certain applications or data transfer in
defined file formats. You are indeed correct that one of the FDA
guidelines reference PPharm but I am not sure they would consider this a
recommendation since there are several competing commercial products and
also programs developed internally by pharmaceutical companies or
universities that pharmacokinetic scientists use for their analysis and
presumably submissions. In short I would anticipate no issues with the
use of Kinetica for ANDA applications to the FDA.
More specifically, when InnaPhase developed Kinetica 4 they
incorporated several features including the algorithm from PPharm.
Furthermore extensive internal testing was preformed to compare the two
products before release of Kinetica 4. I shall enquire as to whether
these results could be made available to you should you wish to examine
them for yourself. The decision to withdraw PPharm was not taken
lightly and I hope you will find many enhancements in Kinetica to the
features you used in PPharm. InnaPhase support for our legacy products
will indeed be phased out as we transfer our existing customers to
Kinetica, however should you have a specific PPharm question we shall
endeavour to respond with a suitable solution.
As regards training in PK/PD there are many excellent courses
avaliable - several are advertised on this mail list; similarly there
are numerous good textbooks. InnaPhase also runs training courses which
cover not just the principles but also how to use Kinetica more
effectively and efficiently. These courses can be run at your own site
or if you prefer you can attend one of our public training sessions; the
next US course will be at our head office in Philadelphia.
I hope this provides some of the information regarding Kinetica
you were seeking; I shall let some of the more experienced contributors
make their own reccommendations on texts and courses. Please do not
hesitate to contact either myself or one of my colleagues at
support.-a-.innaphase.com if you should require any further assistance and
hope that you continue to use InnaPhase's software solutions.
Best regards,
Simon.
Simon A A Davis, B.Sc.
European Technical Support Scientist
InnaPhase Limited UK
Deacon House
St Mary's Court, Amersham
Buckinghamshire, HP7 0UT
United Kingdom
Cell phone : +44 7980 832 666
Telephone : +44 1494 582 080
Facsimile : +44 1494 582 454
Confidentiality Notice: This e-mail transmission contains confidential
or legally privileged information that is intended only for the
individual or entity named in the e-mail address. If you are not the
intended recipient, you are hereby notified that any disclosure,
copying, distribution, or reliance upon the contents of this e-mail is
strictly prohibited. Any views or opinions expressed by the sender do
not necessarily represent those of InnaPhase Ltd. If you have received
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