Pirana

Pirana is a flexible and extendible modeling workbench with an intuitive graphical user interface for facilitating pharmacometric workflows for NONMEM, PsN, Xpose/R, and more. Pirana’s research tools facilitate the iterative processes used to create Pop PK/PD models, resulting in better organization and more efficient analysis of results.

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Changing the Game in Oncology Drug Development and Patient Access

Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

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Computational Comparative Pharmacology: Designing Better Drugs for Animals (and Humans)

Modeling and simulation can help veterinarians provide better care for animals and guide research study design thereby maximizing the knowledge gained from research studies whilst minimizing the number of animals used. In this webinar, we looked at how PBPK modeling can be used to predict the absorption, distribution, metabolism, and excretion of drugs in humans and other animal species.

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Managing Immunogenicity Using Quantitative Systems Pharmacology

Piet van der Graaf

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

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

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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