Systems Pharmacology

Quantitative Systems Toxicology—Taking the Cue from Aristotle

Maria Saluta

“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 […]

Read More
Topics: Systems Pharmacology

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

Maria Saluta

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 […]

Read More
Topics: Model-based Meta-analysis, PK/PD Modeling & Simulation

Navigating the Path for Pharmacokinetic CDISC Data Preparation

Maria Saluta

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 […]

Read More
Topics: PK/PD Modeling & Simulation

What’s New in Phoenix 7.0!

Maria Saluta

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 […]

Read More
Topics: PK/PD Modeling & Simulation

On the Road Again: Leveraging the Power of Phoenix

Maria Saluta

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 […]

Read More
Topics: PK/PD Modeling & Simulation

Get Ready for CDISC-SEND!

Maria Saluta

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 […]

Read More
Topics: PK/PD Modeling & Simulation
Learn More LinkedIn Twitter Facebook Email