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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 … Continued

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 … Continued

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.

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 … Continued

EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update – Major Changes Several major changes are noted in this … Continued

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