Phoenix WinNonlin 8.0 takes non-compartmental analysis (NCA) to a new level by adding many new features to minimize post-processing work and increase transparency with analysis. Additionally, a new validation suite is embedded within the Phoenix 8.0 application and provides an affordable, turnkey process that is significantly faster than other validation options.
Phoenix 8.0 continues to set the gold standard in PK/PD software by delivering innovative features that streamline PK/PD analysis and outcomes, saving time, reducing errors, and providing regulatory agencies with more transparency into the analytical process.
Many people in the UK and elsewhere are currently remembering where they were and what they were doing on the day that Diana Princess of Wales died: August 31st marks 20 years since that fateful day. For Clinical Pharmacologists, we may well remember where we were when we heard the news that six volunteers were […]
In this webinar, Mr. Steve Sibley defined best practices for establishing submission timelines that won’t change, addressed regional differences to minimize document re-work when submitting to multiple countries, and identified leadership and project management skills helpful to regulatory writing.
PRINCETON, NJ – Sept. 13, 2017 – Certara today announced that Kyowa Hakko Kirin Co., Ltd. has joined the Simcyp Consortium and licensed the Simcyp Population-based Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical company and the 11th Japanese pharmaceutical company to join the Consortium.
Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]
PRINCETON, NJ – Sept. 6, 2017 – Certara today announced that its comprehensive influenza viral kinetic modeling review has just been published in Current Pharmacology Reports. As the number of drug-resistant influenza strains grows, researchers are searching for better ways to develop safer, more effective anti-viral drugs. Viral kinetic modeling, in combination with PK/PD modeling, is proving to be a fruitful resource.
With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]
“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]