"PK/PD Laboratory - Hands-on PK evaluation"

From Tuesday, September 07, 2004, 08:00 AM
To Friday, September 10, 2004, 05:00 PM

Enjoy our offer to

"BRING YOUR OWN DATA"
"SEE HOW EXPERTS ANALYZE THEM"
"DEVELOP STRATEGIES OF PK/PD ANALYSIS"

For prior submission of data for our "Bring Your Own Data" offer, please follow the instructions under this link.

You may submit your data via email to bulitta@ibmp.osn.de . Please indicate in the email text, when you would like to discuss the analysis of your data at the PK/PD Laboratory. For sophisticated PK/PD analyses you may also discuss strategies with the experts. Thus, we could reserve time slots for you. We would very much appreciate submission at your earliest convenience. Submissions will be reserved on a "first come first served basis".

As far as confidentiality is a concern, please omit the name of the compound. You may multiply the concentration and/or time axis by any number. This will affect the results, but not the methods and principles applied.

Please note, Pharsight offers a Pharsight Academic Licensing (PAL) program for academic, research, and educational use of Pharsight products at selected Academic Institutions. This program allows academic institutions the use of Pharsight software products free of charge. License conditions can be found under this link.

The following Pharsight software products will be presented by senior experts at the PK/PD Laboratory:

WinNonlin is a PK/PD software that provides a complete solution with analysis, statistics, modeling, and visualization tools included in one package. Its intuitive interface and flexible framework facilitate the use of this powerful application.

WinNonlin is a software that can be applied for high-throughput pharmacokinetic analysis. However, any kind of linear and nonlinear regression can be performed with WinNonlin. It is no way limited to first order differential equation systems. Its Table generator and Graph Wizard as in-built features allow extremely fast overviews even for large datasets.

After PK/PD evaluation, statistical analyses (including average and individual bioequivalence, ANOVA and ANCOVA) can be performed by non-professional statisticians. It may take only minutes from starting with concentration time raw data to the final statistical analysis (even for beginners).

As a guide to pharmacokinetic and pharmacodynamic theory as well as applying modeling concepts using WinNonlin, a very valuable resource is "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications", 3rd Edition, by Johan L. Gabrielsson, Ph.D. and Daniel L. Weiner, Ph.D.

Feature list of WinNonlin

Conducting population PK/PD analysis is particularly important in later phases of clinical trials. Population PK/PD modeling can directly include subject specific factors like sex, ethnic group, age, renal function, weight, etc. in the analysis. This allows subgroup analysis and provides a basis for understanding any differences that may exist.

WinNonMix is a sophisticated program for nonlinear mixed-effects modeling provided in an interactive and easy-to-use Windows application. Users of WinNonlin will find it very easy to learn because the WinNonMix user interface is almost identical to it.

Feature list of WinNonMix

Before starting each actual clinical trial, the Pharsight Trial Simulator provides
quantitative data to answer questions such as:

- What is the optimal treatment schedule of a drug for a particular indication?
- What is the expected range of response?
- How will a change in inclusion/exclusion criteria affect outcome?
- How frequently should the response be measured?
- What is the impact of poor compliance and how can the trial design be improved?

In the late Phase 2 and Phase 3 trials, use of the Pharsight Trial Simulator may eliminate costly missteps and accelerates progress along the path to approval and marketing.

Feature list of the Pharsight Trial Simulator