PK/PD Modeling & Simulation

Can Modeling & Simulation Inform Personalized Medicine?

Kevin Feng

Pharma faces an existential crisis. The cost and time lines of developing new medications have been growing exponentially for decades, with no end in sight. Could modeling and simulation approaches be the Next Great Hope for ending this madness and restoring sustainability to drug development? At the same time, can it deliver on the promise of […]

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Topics: PK/PD Modeling & Simulation

The Ultimate Guide to the Biosimulation Revolution

Ellen Leinfuss

In my work with biopharmaceutical companies, universities, and regulatory agencies, I fly a lot. Looking out the airplane window, the revolutionary impact of biosimulation on drug development struck me. Unfamiliar with the concept of biosimulation, or modeling and simulation (M&S)? You can think of it as the vast improvements in air travel that have been […]

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

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Suzanne Minton

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the […]

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

Modeling the Influence of Ethnicity on Drug Disposition

Zoe Barter

Ever noticed how people from different ethnic backgrounds respond differently to drugs? For example, you may enjoy having a few drinks with friends on the weekend.  When your friends with Eastern Asian heritage drink alcohol, it’s not uncommon for their faces to turn red. This happens because many East Asians possess an enzyme deficiency for […]

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Topics: PBPK Modeling & Simulation

Assessing the Impact of Liver or Kidney Disease on Pharmacokinetics

Trevor Johnson

Impaired hepatic or renal function can have a major impact on pharmacokinetics. There is a high risk of adverse events in patients with these conditions. Major pharmaceutical companies and drug regulatory agencies use physiologically-based pharmacokinetic (PBPK) modeling in virtual populations to investigate the impact of hepatic or renal impairment on drug exposure as a supplement to […]

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Topics: PBPK Modeling & Simulation

Postcards from the Road: Phoenix Fall Tour

Ana Henry

We’ve just returned from the third leg of our now annual Phoenix roadshow. In this leg, I helped deliver workshops in Beijing, Osaka and Tokyo. In total, our product development team has visited eight cities in the US, Europe and Asia.  We gave both technical and scientific PK/PD modeling presentations to more than 250 clients. […]

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Topics: PK/PD Modeling & Simulation

9 Frequently Misunderstood Concepts in PK/PD Modeling

Nathan Teuscher

In teaching pharmacometrics, I’ve noticed that scientists have difficulty with certain PK/PD modeling concepts. Maybe you’ve read about some of these terms in journal articles, but didn’t know what they meant? Or you’ve heard these terms bandied about by colleagues, but felt too shy to ask them what they meant? I’ll clarify some important concepts […]

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Topics: PK/PD Modeling & Simulation

Using Modeling and Simulation to Support Approvals for Orphan Drugs

Suzanne Minton

Rare diseases affect fewer than 1 in 2000 people. Each one affects only a small number of patients. Yet, there are over 7000 rare diseases. And, there are no treatments for 95 percent of them. Thus, many patients suffer from these diseases. The treatments for rare diseases are often referred to as “orphan drugs.” Orphan […]

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Topics: PK/PD Modeling & Simulation

How Modeling and Simulation Technology Could Save Us from the Zombie Apocalypse

Martin Beliveau

Skeptical at the idea of ravenous brain-eating undead? You don’t have to take my word for it. The Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response recognizes this threat. Their Zombie Preparedness website provides information on getting ready for all kinds of disasters. Modeling and simulation (M&S) technology can […]

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Topics: PK/PD Modeling & Simulation

Analyzing Complex In Vitro Experiments: It’s Not as Hard as You Think

Krishna Machavaram

Analyzing in vitro experiments can be challenging and time consuming. Yet, crucial decisions depend on accurate data analysis and interpretation early in development. Unfortunately, most lab-based scientists lack access to state-of-the-art models for analyzing in vitro data. A new tool enables the analysis of data generated from complexin vitro studies. These studies include assays using […]

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

Is Your Approach to Regulatory Writing the Elephant in the Room?

Steve Sibley

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this: A group of blind men hear that an elephant has arrived in their village. Being blind, […]

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Topics: Regulatory & Medical Writing

How to Optimize Your Drug Label Using Modeling and Simulation Technology

Steve Toon

As a trained pharmacist and scientist, I think a lot about patient care and how the drug development process impacts drug labels and the clinical use of medicines. Modeling and simulation technology encompasses methods such as physiologically based pharmacokinetic (PBPK) models. PBPK provides insight into drug mechanisms. It also helps clinicians provide the safest and […]

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Topics: PBPK Modeling & Simulation

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Kelley Hill

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU […]

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Topics: Regulatory & Medical Writing

9 Things Your Boss Wishes You Knew About PK/PD Modeling

Nathan Teuscher

Over the course of my career, I have taught the theory and practical applications of PK/PD modeling to hundreds of scientists. In this blog post, I’ll share some of my most popular tips for solving common difficulties encountered by pharmacometricians. The tools of the trade While I have worked with a number of pharmacometrics tools, I […]

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Topics: PK/PD Modeling & Simulation

The Future is Now: How 3D Printing Could Deliver Personalized Medicine

Adam Calderon

“It will take a few minutes to upload the instructions for your prescription to the 3D printer. We will call you once your medication is ready to be picked up.”  While it seems like science fiction, your pharmacist may describe filling your prescription using this emerging technology sooner than you might think. In this blog […]

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Topics: PK/PD Modeling & Simulation

The Anatomy of a Great Modeling and Simulation Project

Nastya Kassir

In therapeutic areas with tough competition, it is challenging to establish a complete, confident understanding of a drug’s safety and efficacy profile. Any misunderstanding of a drug’s characteristics can derail the entire development program. Modeling and simulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, […]

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Topics: PK/PD Modeling & Simulation

Improve Your Approach to Sharing Clinical Trial Data

Kim Green

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

The Best Meds for Man’s Best Friend: PBPK Models for Animal Health

Devendra Pade

When people find out that you’re working to improve drug development for companion animals, you hear some colorful stories. The other day, one of my colleagues recounted to me the wild antics of Jinjer, her childhood dog. Jinjer was a 60 pound, fawn boxer, with a tiny stump of a tail, who loved everyone. This […]

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Topics: PBPK Modeling & Simulation

How Pharmacometric Analyses Can Add Value to Oncology Drug Programs

Suzanne Minton

We are standing on the precipice of a new era in oncology drug development. In his Pulitzer prize winning book, The Emperor of All Maladies: A Biography of Cancer, Dr. Siddhartha Mukherjee traces the evolution of the approach to treating cancer. He identifies four major paradigms in our understanding of this disease: Ancient views of […]

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

Derivation for Logarithmic Trapezoidal AUC Calculation

Nathan Teuscher

Calculating area under the curve requires the use of two separate equations: one is follows the “linear trapezoidal rule” and the other follows the “logarithmic trapezoidal rule.” These equations are normally presented in textbooks without derivations so all you have to do is insert the concentrations and times and you can calculate the area under […]

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Topics: PK/PD Modeling & Simulation
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