Feedback from the Phoenix Community: Our Visits with the FDA

Nathan Teuscher

We recently completed a week-long set of meetings with the FDA, where we met with over 300 FDA reviewers from 7 of the 11 FDA centers that use Phoenix. Here are a few topics that took center-stage during our visits: Q: How can we create Phoenix workflow templates that are reusable across different studies with […]

Read More
Topics: PK/PD Modeling & Simulation

Modeling PK/PD Systems with Distributed Delays

Suzanne Minton

Many biological systems exhibit time delays. For instance, there is a delay between the time that a virus infects a cell and the onset of viral production. Mathematical models that incorporate these temporal delays are often used to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of drugs. In this blog post, I’ll discuss some examples of biological systems […]

Read More
Topics: PK/PD Modeling & Simulation

Expanding the Use of Pharmacometrics in Japan with Yusuke Tanigawara

Suzanne Minton

Science is a global endeavor. Indeed, one of the most exciting things about drug development is working with scientists doing important research all over the globe. The use of modeling and simulation (M&S) to support drug development has been embraced by pharmaceutical researchers in some parts of the world and is still gaining traction in […]

Read More
Topics: PK/PD Modeling & Simulation

Modeling Delayed Outcomes in PK/PD Studies Using DDEs

Shuhua Hu

Delays are ubiquitous in pharmacokinetics (PK) and pharmacodynamics (PD) studies. Transit compartment models, described by systems of ordinary differential equations, have been widely used to describe delayed outcomes in PK and PD studies. The obvious disadvantage for this type of model is it requires manually finding proper values for the number of compartments. In addition, […]

Read More
Topics: PK/PD Modeling & Simulation

Accessing Grid Computing from Your Desktop for NLME

Fred Soltanshahi

One of the most challenging aspects of population pharmacokinetic/pharmacodynamic (PK/PD) modeling is the lack of computing power required to solve complex models in a reasonable time frame to support rapid drug development decisions. The explosion of cloud computing resources has provided access to significant computing power to solve these complex models. However, accessing these cloud […]

Read More
Topics: PK/PD Modeling & Simulation

Prediction of Liver Volume; One Size Doesn’t Fit All!

Ben Small

When your physician writes you a prescription, they do so knowing that the dose prescribed will (on average) be safe and beneficial to you, but that it is likely certainly not optimal for you as an individual (as has been the topic of a previous blog post). The balance between absorption, distribution and elimination of […]

Read More
Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Estimation of Tulathromycin Depletion in Plasma and Milk after Subcutaneous Injection in Lactating Goats Using a Nonlinear Mixed-effects Pharmacokinetic Modeling Approach

BACKGROUND: Extra-label use of tulathromycin in lactating goats is common and may cause violative residues in milk. The objective of this study was to develop a nonlinear mixed-effects pharmacokinetic (NLME-PK) model to estimate tulathromycin depletion in plasma and milk of lactating goats. Eight lactating goats received two subcutaneous injections of 2.5 mg/kg tulathromycin 7 days apart; blood […]

Read More
Topics:

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

How to Expedite FDA Approvals of Orphan Drugs

Thomas Peyret

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify […]

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

Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data

Serge Guzy

If ever there was a cautionary tale illustrating the importance of getting allometric scaling of drugs right, it’s the story of Tusko the elephant. In 1962, Tusko was living at the Lincoln Park Zoo in Oklahoma City where he received a dose of the psychomimetic drug, lysergic acid diethylamide, better known as LSD. The dose […]

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