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: PBPK Modeling & 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: PBPK Modeling & Simulation

Prediction of Drug-drug Interactions Arising From CYP3A Induction Using a Physiologically-based Dynamic Model

Using physiologically-based pharmacokinetic modeling, we predicted the magnitude of drug-drug interactions (DDIs) for studies with rifampicin and seven CYP3A4 probe substrates administered i.v. (10 studies) or orally (19 studies). The results showed a tendency to underpredict the DDI magnitude when the victim drug was administered orally. Possible sources of inaccuracy were investigated systematically to determine […]

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Seeing the Strategic Value of Biosimulation Technology

Mark Hovde

They say beauty is in the eye of the beholder. One could also say that the benefits of biosimulation are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, measure, and communicate […]

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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
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