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Trial Simulation: An Innovative Approach to Assess Pediatric Drug Dosing

As a pediatric nephrologist, I help care for some very sick kids. And because our young patients are so ill, it’s a challenge to recruit them into clinical studies. Of course, we want to provide our patients with the best care; getting the dose right on their medications is a big part of that. However, […]

Author(s): Edward Nehus
Solution: PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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Certara Publishes New Report Investigating Success Factors for Outcomes-based Contracting, Giving Guidelines to Pharma and Payers

Analytica Laser and BaseCase Introduce Certara Evidence & Access Solutions for US Managed Markets PRINCETON, NJ – Dec. 19, 2018 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced a new research report that investigates the potential of pharmaceutical outcomes-based contracting. The paper, entitled “Outcomes-based Agreements […]

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Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires […]

Author(s): Graham Scott
Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Highlights of the D360 User Group Meeting

In early October, we held our D360 user group meeting (UGM) in Dublin, Ireland with the goal of fostering community among the users of our scientific informatics platform. In this blog post, I’ll share the UGM highlights and what’s coming up for the next UGM. Goals for this year’s meeting The meeting had three themes: […]

Author(s): David Lowis
Solution: Scientific Informatics
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What’s New in the Simcyp Simulator v18?

Watch this webinar with Nikunjkumar Patel, Shriram Pathak, and Rachel Rose to learn how the latest updates in the Simcyp Simulator v18 will help support developing safer, more effective medications.

Speaker(s): Nikunjkumar Patel, Shriram Pathak, Rachel Rose
Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Using Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients

Physiologically-based pharmacokinetics (PBPK) is a valuable resource to support decisions throughout drug development for sponsors and regulators. PBPK is used extensively to predict drug-drug interactions (DDIs), to inform dosing and clinical study design, to predict drug exposure, to predict variation in drug clearance, and to understand mechanisms of drug disposition. Virtual Twin technology, based on […]

Author(s): Thomas Polasek
Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Central Nervous System, Rare/Orphan Disease
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