Advancing the Science and Engineering the Systems of Model-Based Drug Development
Thursday, October 30, 2014
FROM SECTION: BLOG
Every once in awhile an idea is so cool it knocks your socks off. We want to share those ideas. And we want you to send us ideas that knocked your socks off.
Latest Topic: The value of a conceptual schema.
A worthwhile podcast highlighting the value of a conceptual schema.
FROM SECTION: BLOG
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
FROM SECTION: Modeling and Simulation
Cognigen teams up with Simulations Plus to offer physiologic based pharmacokinetic (PBPK) modeling and simulation consulting services using GastroPlus -- 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.
Harness the power of pharmacometrics.
Raise your hand if you wish there was a way to make drug development more efficient. Guess what? There is. It’s called model-based drug development, and it involves using quantitative analysis to better design protocols, determine dosage levels, and figure out other neat stuff that lead to successful regulatory filings. Once you see how incredible (and cost-effective) pharmacometrics can be, you’ll be hooked.
And not to brag, but here at Cognigen, we’re the experts in model-based drug development. In fact, we’ve successfully implemented modeling and simulation strategies for development programs in nearly every therapeutic category, for pharmas both large and small, from preclinical to phase 4. And when a regulatory agency sees you’ve worked with Cognigen, they know your submission is the real deal.
But honestly, this is just the beginning. We continue to push the envelope to make even greater strides in our science. It’s a little thing we like to call "Pharma of the Future℠". You should check it out.