Advancing the Science and Engineering the Systems of Model-Based Drug Development
Thursday, June 20, 2013
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: Get over it!
Vulnerability is the birthplace of innovation, creativity and change, says researcher Brené Brown in a 2012 TEDTalk.
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.
With the use of modeling, explorations of the determinants of drug efficacy and safety are more thorough, and the analyses provide solid support for dose recommendations and labeling content.
FROM SECTION: PK/PD SUPPORT
You build a dataset. You develop a model. You write a report. You prepare a regulatory submission. Uh oh. Bad news. It bounces back with questions that are a huge pain to answer. What went wrong? Dataset errors? Incomplete analysis plan? Disorganized final report? All of the above?
Protect yourself and your company’s assets against these problems before you send that submission. Let Cognigen be your data detective! We will systematically review data elements, verify analysis variables, review code, verify data integrity, check assumptions, and review documentation for accuracy, completeness, and coherence of the scientific strategy.
Cognigen now provides forensic pharmacometrics. So eliminate the anxiety that grips you as soon as you click SEND and improve your chances of regulatory success. Call Cognigen and relax.
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.