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What the FDA Expects from Your Pediatric Drug Program

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

Author(s): Barry Mangum
Therapeutic Area: Pediatrics
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Phoenix WinNonlin 8.0: Updated NCA Engine and New Validation Suite

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.

Solution: PK/PD Modeling & Simulation
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First-in-human Trials and Going Too FAAH from the Sentry

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 […]

Author(s): Graham Scott
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Kyowa Hakko Kirin Joins Certara’s Simcyp Consortium

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.

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Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

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 […]

Author(s): Tom Snowden
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Paper Shows How Viral Kinetic Modeling Increases Influenza Knowledge & Advances Drug Development

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.

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