Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Graham Scott

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 […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

Graham Scott

In this blog, I will introduce “apocalyptic clinical pharmacology” and provide a framework for using this approach in drug development, which can save resources and time. Apocalyptic clinical pharmacology in drug development provides value offering a framework for thinking about the relationship between the drug dose and the biological system. What is apocalyptic clinical pharmacology? […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

Certara’s Dr. Craig Rayner Awarded 2018 Distinguished Alumni Award for the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University

PRINCETON, NJ – Oct. 24, 2018 – Certara today announced that Craig Rayner, PharmD, MBA, senior vice president, integrated drug development with Certara Strategic Consulting, has been awarded the 2018 Distinguished Alumni Award for the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University.

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Certara Launches BaseCase® Portal™, Enabling Life Sciences Companies to Deliver Therapeutic Decision-making Apps to HCPs at the Point of Care

PRINCETON, NJ – Sept. 26, 2018 – Certara announced today the launch of its BaseCase Portal cloud-based platform, that allows for the rapid creation of fully-customizable mobile apps that connect live to mathematical models and algorithms, and help HCPs optimize treatment for individual patients.

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Clinical Pharmacology Gap Analysis: Your FAQs

Julie Bullock

As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Clinical Pharmacology Gap Analysis: Lessons Learned

Julie Bullock

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology

In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.

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