PBPK Modeling & Simulation

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Suzanne Minton

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s […]

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Topics: PBPK Modeling & Simulation

Tips for Custom IVIVC Models in Phoenix

Simon Davis

The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-in vitro correlation model using dissolution experiments and real in vivo profiles. This module can support your organization in formulation development and even in applying for biowaivers. The tool has a flexible library of built-in models that can be modified […]

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Topics: PK/PD Modeling & Simulation

How Biosimulation Can Bring New Immuno-oncology Treatments to Patients

Rik de Greef

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD […]

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Topics: PK/PD Modeling & Simulation

Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?

Venkateswari Muthukrishnan

An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters (Cmax, AUC) from in vitro dissolution data. Drug developers use IVIVCs for 3 major reasons: To serve as a surrogate for human bioequivalence (BE) studies To support and/or validate the use of dissolution methods and specifications To assist in quality […]

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Topics: PK/PD Modeling & Simulation

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
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