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
Leading the way to high-quality, timely analysis-ready data set delivery
Cognigen, a SimulationsPlus company has long stressed the need to address the data assembly challenges of model-based drug development. This project takes a new look at the data requirements specification process in light of the emergence and broad acceptance of CDISC standards. We see first hand, the struggle that companies have in data programming and the delivery of high quality data. Our systematic approach to requirements definition has broad applicability and we would be happy to discuss opportunities to deploy a customized data requisition system for your company.
Better understand the PBPK behind your compounds.
SimulationsPlus Buffalo NY and Lancaster CA offices offer physiologically based pharmacokinetic (PBPK) modeling and simulation consulting services using GastroPlusTM—the pharmaceutical industry’s most sophisticated platform for the prediction of drug absorption and disposition in human and animal species. We can work with you to:
- Identify mechanistic explanations for unexplained variances in absorption characteristics and bioavailability results and use that information to guide population PK and PD modeling and simulation efforts
- Predict drug behavior in pediatric patient populations and perform clinical trial simulations to ensure patient safety and optimize efficacy outcomes in clinical trials while minimizing number of subjects needed.
- Perform PBPK modeling of preclinical data to define dosing strategies for First in Human (FIH) studies
And this is just the beginning… READ MORE