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サターラ、新薬候補の望ましくない副作用リスクを早期に予測するSecondary Intelligence™ソフトウェアを発表

First-of-its-kind software predicts likelihood of off-target safety issues that could impede clinical progress PRINCETON, NJ – 2021年5月4日, Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ(Nasdaq:CERT) はCERT), the global leader in biosimulation, today announced the launch of its Secondary Intelligence™ software, the first and only software that quantitatively predicts the risk of adverse effects and safety issues derived from … Continued

The Impact of Genetic Polymorphisms and DDIs on Exposure

Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the … Continued

年次報告-Simcypコンソーシアム会議

It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic … Continued

Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn’t good for your health. But, did you know that smoking can affect the metabolism of other drugs and even cause serious drug interactions? In this blog post, I’ll discuss the mechanisms by which smoking can impact pharmacokinetics, how physiologically-based pharmacokinetic … Continued

The Next Horizons in Predicting Drug-drug Interactions

Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population … Continued

Seeing the Strategic Value of Modeling and Simulation Technology

They say beauty is in the eye of the beholder. One could also say that the benefits of modeling and simulation (M&S) are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, … Continued

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the … Continued

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