Clinical Pharmacology Strategy

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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Validate Your Expertise in PK/PD NCA Analysis Through Certara Professional Certification

Maria Saluta

In the ongoing commitment to education and coinciding with the launch of Phoenix 8.1, Certara has introduced a new certification program available through Certara University. The new online accreditation program validates the scientists’ PK/PD data analysis skills using Certara software such as Phoenix WinNonlin and expands their professional reach. I caught up with Ana Henry, […]

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

Overcoming Pitfalls and Challenges with Software Validation

Noreen Muscat

As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]

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Topics: PK/PD Modeling & Simulation

Accomplish More with Phoenix

Venkateswari Muthukrishnan

Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be available on June 15, 2018. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features […]

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Topics: PK/PD Modeling & Simulation

Accomplish More with Phoenix—New Phoenix 8.1 Release in June 2018!

As the gold standard for PK/PD software, our upcoming Phoenix 8.1 release delivers new capabilities to automate processes, reduce errors, and save you time. Dr. Nathan Teuscher, VP of Pharmacometric Consulting, Venkateswari Muthukrishnan, Phoenix WinNonlin Product Manager, and Ana Henry, Executive Director of Training, shared our latest innovations in WinNonlin and NLME and conducted a live demo.

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Spotlight on the PAGE Student Sponsorship Winners

Suzanne Minton

When I attend scientific conferences, I feel as though I have reached my own personal “Nerdvana.” I love everything about them! I love going to the sessions and learning the latest cutting edge insights from the leaders in our field. I love walking the aisles of posters and getting to talk one-on-one with scientists about […]

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Topics: PK/PD Modeling & Simulation

Pharmacometrics Skills Competition MIDD Gran Prix

Julie Dumond

Sitting around the Certara’s Raleigh office conference room, sketching out a pitch for a pharmacometrics contest at a national meeting, none of us were overly confident in its viability. Mark Lovern had been talking about the importance of communication skills for pharmacometricians. For them to influence critical drug development decisions, they should be able to […]

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Topics: PK/PD Modeling & Simulation
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