Mechanistic Modeling of Genome Scale Molecular Interaction Networks

Andrzej Kierzek

Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study […]

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Topics: PBPK Modeling & Simulation, Systems Pharmacology

Nurturing the Pharmacometricians of the Future

Suzanne Minton

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

PBPK Modeling of Supersaturating Drug Product Behavior

David Turner

The problem of supersaturating drug products might loosely be summed up as: “If you’re not part of the solution, you’re part of the precipitate!” Indeed, more than 60% of new drug candidates are poorly soluble1 which can severely limit their bioavailability. To ameliorate this issue, a common approach is formulating to create supersaturated solutions of […]

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Topics: PBPK Modeling & Simulation

Predicting Drug Exposure During Pregnancy Using PBPK Models

Suzanne Minton

Moms want the best for their kids even before they’re born. When I was pregnant with my son and daughter, I watched my diet and tried to stay active. During both of my pregnancies, I had to take medications several times. And I was always concerned about whether the medications could impact my unborn children. […]

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Topics: PBPK Modeling & Simulation

New Tools Support Developing Better TB Drugs

I. Gardner & O. Hatley

Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the […]

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Topics: PBPK Modeling & Simulation

The Ides of March—FDA’s Pharmaceutical and Clinical Pharmacology Advisory Committee Meeting

Ellen Leinfuss

While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.

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Topics: PBPK Modeling & Simulation

The Model-informed Precision Dosing Revolution Is Coming

Suzanne Minton

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

Leveraging PBPK Modeling and Simulation for Neonatal and Infant Drug Development

Alice Ke

Despite increased regulatory support for pediatric drug development, sponsors still face ethical, economic and practical constraints. Indeed, while children represent about 40% of the world’s population, only 10% of the drugs on the market have been approved for pediatrics. Children are not small adults, and all children are not the same. In particular, children under […]

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Topics: PBPK 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 […]

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

Transforming Drug Product Development the PBPK Way!—A Breakthrough Approach

Shriram Pathak

Developing and optimizing drug formulations― a key component of a product development―is a very lengthy and capital intensive process. Today, most drug candidates are poorly water-soluble; this has led to greater emphasis on screening more complex formulation technologies. Formulation development is still largely an empirical process ― based on trial and error and formulation scientists’ […]

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Topics: PBPK Modeling & Simulation

Best Practices in PBPK: The Case of Efavirenz

Lisa Almond

According to the FDA’s Guidance for Industry on Drug-drug interactions (DDIs), assessment of a new drug’s DDI liability has three major objectives: determining whether any interactions necessitate dosing adjustment, informing the extent of therapeutic monitoring that may be required and identifying any potential contraindications to concomitant use when lesser measures cannot mitigate risk Physiologically-based pharmacokinetic […]

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Topics: PBPK Modeling & Simulation

How PBTK Models Support Toxicological Triage

Suzanne Minton

Did you know that only a small fraction of the tens of thousands of commercially-used chemicals have undergone toxicological assessment? Time and cost constraints, not to mention the ethical impossibility of studying these chemicals in human trials, hamper large-scale toxicological assessment. Physiologically-based toxicokinetic (PBTK) models can be leveraged to predict TK from in vitro measurements […]

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Topics: PBPK Modeling & Simulation

The Impact of Genetic Polymorphisms and DDIs on Exposure

Suzanne Minton

Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the […]

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Topics: PBPK Modeling & Simulation

Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug

Karen Rowland Yeo

Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone […]

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Topics: PBPK Modeling & Simulation

Annual Report—Simcyp Consortium Meeting

Ellen Leinfuss

It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic […]

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Topics: PBPK Modeling & Simulation

How PBPK Can Help Solve Fatal Poisonings

Suzanne Minton

My mom― a clinician scientist herself― would often say this about the power of pharmacology: Every medicine has its price. While most patients benefit from their medications, cases of fatal drug poisonings are tragedies wherein patients pay the ultimate price. Forensic toxicology probes cases of fatal poisonings where the cause of death is unknown. This […]

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Topics: PBPK Modeling & Simulation

6 Real-life Lessons About PBPK Modeling

Suzanne Minton

I recently had the pleasure of attending a 1.5 day Certara forum for management on the applications of physiologically-based pharmacokinetic (PBPK) modeling and simulation in Chicago, IL. Our CSO Dr. Amin Rostami and Certara consulting scientist, Dr. Alice Ke aptly led the forum. The highlight of the meeting was discussing the latest challenges and trends […]

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Topics: PBPK Modeling & Simulation

FDA’s PDUFA VI Goals Highlight Model-informed Drug Development

Ellen Leinfuss

On July 15, the US FDA published its goals and commitment letters for the re-authorization of its Prescription Drug User Fee Act (PDUFA) for fiscal years 2018-2022, known as PDUFA VI.  The document reflects the agency’s performance and procedural goals to expedite bringing safer therapies to patients.  It also reflects and incorporates the advances in […]

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Topics: PBPK Modeling & Simulation

Assessing Drug-smoking Interactions Using PBPK Modeling

Theresa Cain

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn’t good for your health. But, did you know that smoking can affect the metabolism of other drugs and even cause serious drug interactions? In this blog post, I’ll discuss the mechanisms by which smoking can impact pharmacokinetics, how physiologically-based pharmacokinetic […]

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Topics: PBPK Modeling & Simulation

Using PBPK Models to Optimize Antiviral Dosing at the Point of Care

Manoranjenni Chetty

The use of physiologically-based pharmacokinetic (PBPK) modeling for drug development is well-established and is now routinely used by the pharmaceutical industry, regulators, and researchers. In this blog post, I’ll discuss a novel application that combined PBPK and Bayesian modeling to help clinicians optimize dosing at the point of patient care. This application was used to […]

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Topics: PBPK Modeling & Simulation
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