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: History of Pharma of the Future
Pharmacometric modeling and simulation has moved from its infancy as a novel way of approaching the analysis of clinical pharmacokinetic data to become an invaluable tool in pharmaceutical and biotechnology research and development. Early, tentative applications of modeling have given way to robust model-based drug development activities in which pharmacokinetic and pharmacodynamic modeling and simulation results are widely utilized to improve the probability of successful clinical trials. Pharma of the Future Historical Time Line
A Fresh Approach to "Clouded" Thinking
Latest Topic: Rethinking Scientific Workflows
While we now have access to adequate computing power for most applications, we lack the tools required to properly manage the investigative process. We need the tools to organize the results of the numerous model configurations, sort through the results and compare alternative formations of the model in order to determine reasonable next steps and decide that a particular model or group of models is adequate for the task at hand. And this is where the idea of “workflow” comes to the forefront.
Phase 1 Studies - The Pursuit of Excellence in Early Clinical Development
Phase 1 studies provide the first indications of a new drug’s pharmacokinetic and safety characteristics in humans, and they set the stage for the design of phase 2 and 3 clinical trials. Consequently, Cognigen understands that careful attention to the design and execution of phase 1 studies, to the analysis and interpretation of data, and to the preparation of reports are essential for successful drug development. Each study must be viewed as an integral part of the knowledge base that accumulates about a drug from discovery to registration. This knowledge base serves as the foundation for decision-making throughout the drug development process.
Have a question about our Phase 1 Pharmacokinetic and Biomarker Services - send us a note!
Better understand the PBPK behind your compounds.
Cognigen teams up with Simulations Plus to 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