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: Drug Safety, PBPK Modeling and 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 and Simulation

Revolutionizing Drug Development— d3 Medicine Joins the Certara Family

Craig Rayner

Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which […]

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Topics: Clinical Trial Design, Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and 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: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and 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: Drug Safety, Model-based Drug Development, PBPK Modeling and 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: Drug Safety, Model-based Drug Development, PBPK Modeling and 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: Model-based Drug Development, PBPK Modeling and 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: Clinical Trial Design, Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation

How to Expedite FDA Approvals of Orphan Drugs

Thomas Peyret

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 […]

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and 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: Model-based Drug Development, PBPK Modeling and 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: Model-based Drug Development, PBPK Modeling and 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: Drug Safety, Model-based Drug Development, PBPK Modeling and 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: Model-based Drug Development, PBPK Modeling and 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 efficacy1, 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 […]

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and 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.”

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Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and 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 and Simulation, PK/PD Modeling and Simulation

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 and Simulation

How Biosimulation 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: Model-based Drug Development, PBPK Modeling and 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: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation

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: Drug Safety, PBPK Modeling and Simulation
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