Model Firsts

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions.

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Beam Me Up, Scotty! Probing the Mechanisms of Transporter-mediated Drug Disposition

Matthew Harwood

Over the last 15 years, the importance of drug transporters has become paramount for understanding drug absorption, distribution into tissues, and in particular, drug-drug interactions (DDIs). In vitro-in vivo extrapolation (IVIVE) is an approach to link in vitro systems to the human in vivo situation using algorithms and physiologically-based scaling factors. In this blog, I […]

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Topics: PBPK Modeling & Simulation

Shanghai Workshop: November 2018

Model-informed Drug Development Incorporating population variability into mechanistic prediction of PK and modeling PK/PD November 26–30 in Shanghai, China Delegates will learn how to simulate: Metabolic drug clearance (CL) Metabolic drug-drug interactions (DDIs) Gut first-pass metabolism Oral drug absorption incorporating food effects and the impact of dosage form Effect of transporters and enterohepatic recirculation on […]

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Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

Nikunjkumar Patel

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have […]

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Topics: PBPK Modeling & Simulation

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
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