Advancing the Science and Engineering the Systems of Model-Based Drug Development
The pharma industry is evolving at a breakneck pace. But luckily, we're here to keep you up to speed on what's happening in drug development.
Latest Topic: Global Health Initiative
Envisioned by Cognigen Corporation, a Simulations Plus (Nasdaq:SLP) company, in 2003, the Pharma of the FutureSM (PoF) program was conceived as a research and training initiative to design and implement the workflows and computer systems required to support modeling and simulation (M&S) activities. The numerous M&S projects performed by Cognigen scientists became a source of raw material for research initiatives designed to improve the quality, timeliness, and impact of M&S results. These research initiatives have yielded numerous benefits, including:
- Formalized data definitions and data programming requirements that enable the timely delivery of quality data for analysis
- A robust informatic infrastructure and computer system which became the foundation for the KIWITM platform
- A variety of internally and externally focused training programs to advance the science and technology required for planning, executing, and reporting M&S efforts
- Click here for more information about the PoF program.
A Fresh Approach to "Clouded" Thinking
Latest Topic: Visualize in KIWI 1.5 - Available Now!
New Features in KIWI 1.5:
KIWI 1.5 continues to bring user experience to a new level through efficient, decisive model building and co-worker collaboration.
Visualize - Visualize diagnostic plots and parameters for all candidate models in one view
Formats / Labels - Fully customized formatting and labeling within KIWI
Cross Project and Co-Worker Graphical Profiles - Share your share suite of customized diagnostic plots with your co-worker or use them on your next project
PK and Exposure-Response Model Development
Using population-based pharmacokinetic models, we can characterize drug disposition using sparse drug concentration data in patients with the condition of interest, whereas characterizing the relationships between drug exposure and patient response is done using exposure-response models. By gaining this understanding, we can support the selection or justification of dosing strategies, determine the maximum tolerated dose or the minimum effective dose, and characterize sub-population differences or drug-drug interaction effects for inclusion in the drug’s labeling information.
Clinical Trial Simulations
We use population PK/PD models to simulate a clinical trial, which can test the impact of study designs on trial outcomes. With this method, various “what if” scenarios can be evaluated with replication to provide confidence in designing future trials.