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: Run Record for Model Development
The EMA and FDA recommend including a run record in your technical report to describe any major decisions and should include an overview of the steps taken during model development. KIWI 1.3, available in May 2015, will reduce the time taken to perform this task to just minutes.
CDISC Data Assembly Services.
You’ve trusted Cognigen to build your NONMEM datasets, now let us build your CDISC SDTM domain and ADaM datasets. READ MORE....
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