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A Practical Approach to the Challenges of Pediatric Drug Development

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

Author(s): Barry Mangum
Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
Therapeutic Area: Pediatrics
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Best Practices in Clinical Pharmacology Gap Analysis

Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.

Speaker(s): Julie Bullock
Solution: Clinical Pharmacology Strategy
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FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.

Solution: PBPK Modeling & Simulation
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D360 Partner

D360 Partner is an affordable add-on product for D360 for external partners that allows for seamless, secure sharing of data and analysis while advancing communication and collaboration.

Solution: Scientific Informatics
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Trial Simulator Engine (TSE)

Certara’s Trial Simulatior Engine is a tool with a command-line interface that can be used to determine the effects of variability in drug and subject characteristics on the likelihood of trial success. Users can conduct sequential and parallel subject simulations for real-world trial simulations.

Solution: PK/PD Modeling & Simulation
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Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]

Author(s): Ellen Leinfuss
Solution: PBPK Modeling & Simulation
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Phoenix Modeling Language School: The Semester in Review

Phoenix® WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and pharmacodynamic (PD) models. Although most models can be built using the Phoenix graphical user interface (GUI), some models require custom coding with PML. During the latter part of 2016, Certara’s support team, led by Dr. Bernd Wendt, Director of Training and Support, introduced […]

Author(s): Maria Saluta
Solution: PK/PD Modeling & Simulation
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