The Certara Blog: PK/PD Modeling & Simulation

What the FDA Expects from Your Pediatric Drug Program

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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New FDA Commissioner Endorses Use of M&S to Advance Drug Development

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

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Speaking into the Ether: Challenges of the Virtual Pharma Workplace

In today’s global pharma working environment, virtual interactions are sometimes more common than live exchanges. Many people work virtually through teleconferences, video conferences, instant messaging, phone calls, and emails. Through flexible schedules and working remotely, some people spend the majority of their day without seeing or hearing their colleagues. Honing your skills Pharmacometricians are like […]

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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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Feedback from the Phoenix Community: Our Visits with the FDA

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 […]

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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 […]

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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 […]

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Nurturing the Pharmacometricians of the Future

As a scientist, you always remember your first conference. The ability to share your research and learn from your peers is an invaluable part of any scientist’s training. That’s why I’m so proud that Certara helps support the travel and accommodation expenses for a selected number of students wishing to attend the Population Approach Group […]

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Using Pharmacokinetics to Assure Chemical Food Safety

As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary medicine because indirect exposure to drugs and their metabolites through eating meat or milk could […]

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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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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, […]

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The Model-informed Precision Dosing Revolution Is Coming

Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient. The […]

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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 […]

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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 […]

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Man trying to choose which path to take

How MBMA Can Help You Make Smarter Drug Development Decisions

Successful drug development depends on making wise decisions about portfolios, clinical trials, marketing, etc. We’re continuously faced with the challenge of deciding whether to continue development or stop it. To support those decisions, we gather data, typically through clinical trials. We analyze the data from those clinical trials, and then we use these analyses to […]

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Using Phoenix for dissolution testing

Leveraging Dissolution Testing to Meet Regulatory Guidelines

Dissolution testing is a standard tool in a formulation scientist’s arsenal. When companies make changes to drug products (particle size, excipients, manufacturing process, equipment, etc), health authorities often require comparing dissolution profiles to determine if the reference and test products are equivalent. Generic drug developers are also required to show bioequivalence between the branded drug […]

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good by to 2016

Optimizing Drug Development Decisions: Looking Back at 2016

Was it just me or did 2016 just seem to fly by? Reflecting on the events of the past year, I stumbled across this quote which seemed appropriate: There are years that ask questions and years that answer. [Zora Neale Hurston, Their Eyes Were Watching God] Our mission at Certara is helping our clients optimize […]

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PML School

PML School: Custom PK/PD Modeling Made Easy

In our increasingly noise-filled world, sometimes, the most powerful insights come from listening. As the head of support at Certara, I get excited about listening to our clients’ pharmacokinetic/pharmacodynamic (PK/PD) modeling dilemmas and helping them solve them. And through listening to our users who call our support hotline, attend our training courses, or participate in […]

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Dec 18 is the deadline for the FDA mandate to use CDISC SEND for submissions

The Ultimate Cheat Sheet on CDISC-SEND

On December 18, 2016, numerous regulatory agencies will require electronic submission of non-clinical data using CDISC’s standard format. What exactly are CDISC data standards and how will they impact drug developers? In this blog post, I will provide an overview of the CDISC SEND data standard, review some of the requirements for implementing SEND, and […]

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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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