The Certara Blog

Author: Maria Saluta

Maria Saluta obtained her BS, MS, and PhD in Microbiology from St. John’s University. Maria has held various research, scientist applications support, and leadership roles in the Life Sciences and Diagnostics industries, and is currently the Sr. Product Marketing Manager for Modeling and Simulation at Certara. In her spare time, she loves to experience the earth and its inhabitants by globetrotting to off-the-beaten path destinations.

Recent Posts

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

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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Using M&S to Evaluate Oncology Drug Dosing

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

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Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD […]

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A Targeted Approach to Medicine and Dosing—A Necessity for Sustainable Healthcare

President Obama, during his 2015 State of the Union Address, launched the Precision Medicine Initiative “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.” The message given to the American people reinforced the critical need to implement precision medicine into […]

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How to Harness Public Clinical Trial Data to Assess Drug Candidates

Publicly available clinical trial data represent an underutilized source of information. If properly extracted and analyzed, the data provide valuable input for facilitating go/no go decisions, performing comparative effectiveness and portfolio evaluations in support of in/out licensing, and optimizing overall drug development decisions, including dose and dosing regimens. Clinical Outcomes Database Explorer, CODEx, is an […]

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Phoenix Modeling Language School: The Semester in Review

Phoenix® WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and pharmacodynamic (PD) models. Although most models can be built using the Phoenix graphical user interface (GUI), some models require custom coding with PML. During the latter part of 2016, Certara’s support team, led by Dr. Bernd Wendt, Director of Training and Support, introduced […]

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Quantitative Systems Toxicology—Taking the Cue from Aristotle

“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]

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What are Clinical Trial Outcomes Databases? How and Why You Should Use Them

Publicly available clinical trial data represents an underutilized source of information. If properly extracted and analyzed, they provide valuable information to support drug development decisions. When you think of the volumes of public information and databases that are available to determine, for example, commercial viability of a therapeutic in development, your first inclination is—“great!” But […]

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Navigating the Path for Pharmacokinetic CDISC Data Preparation

Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the […]

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image of a magnifying glass over the Phoenix 7.0 logo

What’s New in Phoenix 7.0!

On September 14, Dr. Nathan Teuscher presented an informative webinar focused on new features and enhancements in Phoenix® 7.0, which was released on August 10. This blog post summarizes the topics discussed during the presentation. Nathan began his presentation with an overview of new features in Phoenix 7.0 including: A new graphics engine for high […]

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A fiery Phoenix flies over the road

On the Road Again: Leveraging the Power of Phoenix

Last year during our inaugural Phoenix Roadshow workshop program across the US, Europe and Asia, we gained valuable feedback and ideas from our customers on “All Things Phoenix.” Based on the success of that program, and with new updates and case studies to share with our users, we commenced our 2nd Annual Phoenix Roadshow in […]

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data flying out of a open box

Get Ready for CDISC-SEND!

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and […]

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