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The following message was posted to: PharmPK
Dear members,
I am starting to venture into the wonderful world of IVIVC. I'm only
at the early learning stage, but I have some nice in vitro and
corresponding in vivo data from IV, oral solution and a number of
solid oral formulations. I have seen there are dedicated software
packages available that can be of great help in performing IVIVC but I
would like to start form the bottom up so as to develop a strong
knowledge base in the subject. One stumbling block I have met is
performing deconvolution on the pharmacokinetic data. I have designed
a Wagner-Nelson calculation using Excel. I have also found reference
to a program called PCDCON by William Gillespie. However, this
program seems to have disappeared of the internet. I was hoping
someone may have a copy that could be passed on. This would be of
great help.
Many thanks for your time on my posting.
Regards,
Conor
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The following message was posted to: PharmPK
Hi Conor,
There are several IVIVC packages available
One is former Globomax - now ICON. They used to have subscription-only
IVIVC server that implements IVIVC (deconvolution, mean, individual
IVIVC, validation, etc.)
Similar capabilities are now included into Pharsight WinNonlin (add-in
as far as I know)
GastroPlus has both IVIVC and deconvolution available.
Alternative approach has been developed by Adrian Dunne using custom-
written Nonmem code, see for example,
http://www.page-meeting.org/?abstract=1095
There is a package developed in R
http://cran.r-project.org/web/packages/ivivc/index.html
http://pkpd.kmu.edu.tw/ivivc/
but I have not tried it.
PCDCON is not supported for a long time but you can try to ask Bill
directly (google his name, and you will find his e-mail address)
Thanks
Leonid
--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web: www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
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I believe PCDCON is implemented as the "Deconvolution" option in the
WinNonlin 5.2 Toolbox menu. I don't know if this was dropped in the v6.0
(Phoenix).
Cheers... Brian
Brian M. Sadler, Ph.D.
Strategic PK Consulting, LLC
1209 Seabrook Avenue
Cary, North Carolina 27511
USA
bsadler1.-a-.nc.rr.com
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The following message was posted to: PharmPK
Hi Brian,
WinNonlin doesn't use PCDCON algorithm. PCDCON is not constrained so the
results can go un-physiologically negative (although is a bit more
flexible
in its approach). WinNonlin's algorithm is constrained to zero and is
probably the preferred method.
Conor, if you don't have access to WinNonlin, let me know and I'll
send you
PCDCON.
Regards,
Charlie
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The following message was posted to: PharmPK
Hi Conor,
Just to clarify; the Numerical deconvolution tool is implemented
in the base products of both WinNonlin 5.x and the new 6.0 release and
you need not buy the IVIVC toolkit to perform this function. WinNonlin
6 released last week supports all of the models available in the
previous versions of 'base' WinNonlin (including Deconvolution that has
been available since version 3.3 I think).
Leonid is correct that there is an additional add-in "IVIVC
Toolkit" for WinNonlin 5.2.x that adds several additional models as well
as a very popular wizard that manages your IVIVC project data and
workflow; the IVIVC toolkit for version 6 will be released later this
year.
The Pharsight website has more information about the IVIVC
toolkit and other products at
http://www.pharsight.com/products/prod_home.php.
I would also suggest looking at some of the recorded webinars (most
are about 45 minutes long) e.g. IVIVC Applications and Case Studies
under
http://pharsight.com/events/eventsonline_archive.php#replay_015
and also the forthcoming introductory webinars on Phoenix-WinNonlin 6.0
http://www.pharsight.com/events/eventsonline_schedule.php
Best regards,
Simon.
--
Simon Davis
Senior Scientific Consultant
Pharsight- A Certara(tm) Company
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Dear Conor,
You can find details about deconvolution procedures at BEBAC website:
http://www.bebac.at/
[directly at:
http://forum.bebac.at/search.php?search=deconvolution&x=0&y=0
- db]
Please search this topic at the link: Forum.
regards,
Daniel Rossi de Campos
Brazil
[Or the PharmPK archives at:
http://www.boomer.org/htsearch.cgi?config=htdig&restrict=http%3A%2F%2Fwww.boomer.org%2Fpkin%2F&exclude=&method=and&format=builtin-long&sort=score&words=deconvolution
- db]
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I am trying to apply numerical deconcolution to PK data using SAS program codes or using an existing non-comercial software. Would someone be kind enough to send me a copy of the PCDCON software?
I was not able to find the software at all from the internet.
Thank you very much for your help!
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Hello,
I am in a similar boat: I have been looking at WinNonLin, but would like to compare this with other software. I would appreciate anyone's ideas of (free!) alternatives.
Regards,
David
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IVIVC/deconvolution:
One can do it in nonmem (see Adrian Dunn papers/posters); not exactly free but cheaper than other alternative (if in academia) and nonmem can be used for other purposes as well.
The idea is to fit PK model to IV data (thus, get the kernel for the deconvolution), fix the individual PK parameters, and then use some flexible input rate function (Weibull or something similar) as an input to the IV compartment while fitting for oral data. If successful, this input function describes absorption profile, i.e., deconvolution of the oral data given the IV system parameters (e.g., CL, V for the one-compartment system).
In fact, one can directly do IVIVC instead of deconvolution:
-fit IV data to get the system parameters;
-fit in-vitro data to get smooth description of the dissolution profiles
propose
-fit IVIVC model as a link between in-vitro dissolution and PK system to describe observed oral data (details can be found in Adrian's papers)
I have tried this procedure it it worked in a number of cases.
Thanks
Leonid
--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web: www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
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Dear Group,
The IVIVC can be done by using any of the available commercial software like WinNonlin, Kinetica, Gastro Plus. I have explored all the three softwares and with my understanding i found Gastroplus is better software but its quite expensive.
One can make excel programme fo such type of correlation.This can be done easily.
With regards,
Dr. Tushar Nahata
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The following message was posted to: PharmPK
Dear W T!
> I am trying to apply numerical deconcolution [...] using an existing non-comercial software.
>
Maybe the package "ivivc for R" is helpful?
http://pkpd.kmu.edu.tw/ivivc/
Helmut
- Ing. Helmut SchAtz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
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Dear All
We are also trying to use alternative programs to model IVIVC. Can one perform IVIVC using the Scientist(R) program (Micromath)? Can some one share the control stream or code for it.
Any feedback would be appreciated.
Manish
Manish Issar, Ph.D
Project Manager
Applied Biopharmaceutics, LLC
2010 Cascade Drive
Corona, CA 92879
Email: m.issar.aaa.gmail.com
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The following message was posted to: PharmPK
Tushar,
Thanks for the mention of GastroPlus. Please recognize that there are very
substantial discounts on all Simulations Plus software for academic research
only (no commercial use).
The IVIVCPlus Module in GastroPlus provides a complete set of traditional
(Wagner-Nelson, Loo-Riegelman) methods as well as numerical deconvolution
and deconvolution of the in vivo release profile using the full GastroPlus
ACAT model. Deconvolution of the in vivo release profile via a mechanistic
model that accounts for the regional dependencies of permeability,
solubility, dissolution, and precipitation provides much greater insight
into why things are different between in vitro and in vivo
dissolution/release.
The user interface makes it very easy to fit correlations across single or
multiple data sets, and to apply correlations to new in vitro
dissolution-time profiles to get expected plasma concentration-time results.
Running IVIVC's and plotting of a variety of outputs is point and click.
Best regards,
Walt
Walt Woltosz
Chairman & CEO
Simulations Plus, Inc. (NASDAQ: SLP)
42505 10th Street West
Lancaster, CA 93534-7059
U.S.A.
http://www.simulations-plus.com
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The following message was posted to: PharmPK
Hi to all people looking for Bill Gillespie's PCDCON!
For download see here:
http://forum.bebac.at/mix_entry.php?id=4426#p4432
Best regards,
Helmut
- Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
[Thanks Yung-jin and Helmut. I found a manuscript by David Levitt describing some options.
http://www.ncbi.nlm.nih.gov:80/pmc/articles/PMC153531/
and added info about PKQuest and a link to PCDCON on my PK software page
http://www.boomer.org/pkin/soft.html
- db]
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