Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Oliver Hatley

Oncology drug developers face a distinct set of challenges. Oncology drugs are often very toxic which precludes conducting clinical trials in healthy volunteers. In addition, cancer patients differ from healthy people in terms of their demographics and physiology. These changes mean that the pharmacokinetics of drugs may be altered in this population compared to healthy […]

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Topics: PBPK Modeling & Simulation

Using PBPK Models to Assess Fetal Drug Exposure

Rick Greupink

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than 10,000 children had been born with thalidomide-induced birth defects. “Phocomelia,” wherein babies were born with […]

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Topics: PBPK Modeling & Simulation

The Biggest Drug Development News Stories in 2017

Suzanne Minton

When I reflect on the state of drug development in 2017, the opening lines of Charles Dickens’ A Tale of Two Cities comes to mind. It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, […]

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

Using PBPK Models to Optimize Anti-HIV Drug Dosing in Pregnant Women

Angela Colbers

Antiretroviral drugs are a critical tool in preventing mother-to-child transmission of HIV. Yet, antiviral treatment options for pregnant women lag behind the “non-pregnant” population. In this blog post, I’ll discuss the reasons for this lag and how physiologically-based pharmacokinetic (PBPK) models can simulate PK during pregnancy and thus help optimize dosing for this special population. […]

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Topics: PBPK Modeling & Simulation

FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.

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A Chat with Biopharmaceutics Expert, Professor Jennifer Dressman

Suzanne Minton

Professor Jennifer Dressman is fearless—both in her science and her career. Born and raised in Australia, she holds degrees in pharmacy and a doctorate in pharmaceutics. Having held positions at Burroughs Wellcome and the University of Michigan, College of Pharmacy in the United States, she was offered her dream job as a professor at the […]

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Topics: PBPK Modeling & Simulation

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Tom Snowden

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Topics: Systems Pharmacology

Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

In this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.

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