PBPK Modeling & Simulation

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

In this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.

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New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

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. […]

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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

Mechanistic Modeling of Genome Scale Molecular Interaction Networks

Andrzej Kierzek

Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study […]

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Topics: PBPK Modeling & Simulation, Systems Pharmacology

Certara Launches CODEx to Inform Comparative Effectiveness and Drug Development Decisions

PRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.

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