Modeling PK/PD Systems with Distributed Delays

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 … Continued

Expanding the Use of Pharmacometrics in Japan with Yusuke Tanigawara

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 … Continued

Modeling Delayed Outcomes in PK/PD Studies Using DDEs

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, … Continued

Accessing Grid Computing from Your Desktop for NLME

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 … Continued

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

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 … Continued

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 … Continued

How to Expedite FDA Approvals of Orphan Drugs

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 … Continued

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 … Continued

Fighting Superbugs: Supporting FDA Approval of a New Antibiotic

One of the most rewarding parts of leading Certara’s consulting services is recognizing how our work supports new drug approvals to positively impact patients’ health. In this blog post, I’ll discuss how Certara helped Cubist obtain FDA approval for Zerbaxa™ (ceftolozane/tazobactam), a new antibacterial drug to treat adults with complicated infections. The growing threat of … Continued