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

Predicting Variations in Drug Clearance in Obese Patients Using Modeling and Simulation

Trevor Johnson

Many physiological changes are associated with obesity and can potentially impact pharmacokinetics (PK). This can require adjustments to be made to the standard doses for normal weight patients in order to ensure safety and efficacy of drug therapy. Dosing of specific drugs in this population is dependent on their physico-chemistry as well as changes in body […]

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Topics: PBPK Modeling & Simulation

Status of QSP Modeling in the Pharmaceutical Industry

Steve Toon

A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to lack of efficacy,1 suggesting inadequate understanding in therapeutic targets’ biology and their relevance to disease progression or modulation. Quantitative systems pharmacology (QSP) has the promise of increasing the probability of success in R&D by bridging scientific gaps between disciplines to enable […]

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Topics: Systems Pharmacology

Every Ending has a New Beginning

Nathan Teuscher

I created the Learn PK/PD site in May 2010 in response to a communication issue that I was facing in my daily work in the world of clinical pharmacology and pharmacokinetics. In my first post, I stated the reason for creating my blog and the website: My blog is dedicated to providing clear, concise, accurate, and […]

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Topics: PK/PD Modeling & Simulation

Highlights of the Quebec “Drug Discovery to Development” Symposium

Mark Reimer

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit […]

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Topics: PK/PD Modeling & Simulation

Effective Communication for Pharmacometricians with Joga Gobburu

Suzanne Minton

The modeling and simulation revolution is transforming our approach to drug development. Quantitative pharmacology models can yield valuable insights that help sponsors make better decisions regarding their drug programs. For pharmacometricians to influence decision making, they must be able to effectively communicate. Dr. Joga Gobburu is a Professor at the University of Maryland Schools of […]

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Topics: PK/PD Modeling & Simulation

The Special Opportunities for Modeling and Simulation in Oncology Drug Development

Rik de Greef and Ellen Leinfuss

In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.” Oncology treatment: yesterday, today and tomorrow Mukherjee begins his article […]

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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 […]

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Topics: PK/PD Modeling & Simulation

The Rise of Model-informed Drug Development in China

Christine Yuying Gao

China’s pharmaceutical market is poised for growth. By 2020, it is expected to grow to approximately $120 billion. Today, China’s 1.36 billion people represent 20 percent of the world’s population. Yet, they comprise only 1.5 percent of the global drug market. From a demographic perspective, nine percent of the Chinese population today is over 65 […]

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

Diving into Best Practices for Pooling Clinical Trial Data

Steve Sibley

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated […]

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Topics: PK/PD Modeling & Simulation, Regulatory & Medical Writing

Precision Dosing Using PBPK Modeling

Devendra Pade

With the discovery of newer drugs, the “one-size-fits-all” approach towards therapy is becoming a thing of the past. The new paradigm of precision medicine aims at delivering the right treatment at the right time to the right patients. An integral part of precision medicine is administration of a precise dose, which is a critical step […]

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Topics: PBPK Modeling & Simulation

How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

Nirpal Virdee

The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. […]

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Topics: Clinical Transparency & Disclosure

Get Ready for CDISC-SEND!

Maria Saluta

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and […]

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Topics: PK/PD Modeling & Simulation

Reference-scaled Average Bioequivalence

Ana Henry

The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an  approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under […]

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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 […]

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Topics: PK/PD Modeling & Simulation

How Modeling and Simulation Can Provide Insight into Herbal Supplement Safety

Ellen Leinfuss

According to the Council for Responsible Nutrition, a trade group for the $32 billion nutritional supplement industry, 68% of adults take dietary supplements. Further analysis shows that supplement use is more prevalent among women, the children of women that take supplements, and the elderly. Like drugs, supplements do not work the same in all patients […]

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Topics: PBPK Modeling & Simulation

Educating the World in Modeling and Simulation: Creating Certara University

Frank Garafalo

“Fundamentally, Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions. Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first […]

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Topics: PK/PD Modeling & Simulation

Mechanistic Modeling of Antibody Drug Conjugate Pharmacokinetics

Linzhong Li

Antibody Drug Conjugates (ADCs) are constructed by attaching a small molecule drug to an antibody via a linker. The antibody selectively targets tumor cells and releases the cytotoxic drug within the cells to kill cancerous cells while sparing healthy tissue. Although some ADCs have been approved, many unanswered questions remain, such as drug-drug interactions (DDIs) and […]

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Topics: PBPK Modeling & Simulation

Regulatory Writing Experts: Superman or Clark Kent?

Tatyana Wanderer

The day starts out slowly. The clinical lead settles into her comfy chair, pushes up her glasses just a bit and gazes at the shimmering computer screen, as the spring breeze sways the branches on the other side of the window. Then, one email (bing)…two emails (bing, bing)… ten, twenty! The beeps roar like a […]

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Topics: Regulatory & Medical Writing

The Next Horizons in Predicting Drug-drug Interactions

Matthew Harwood

Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population […]

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Topics: PBPK Modeling & Simulation
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