The ISoP Standards and Best Practices Committee

The mission of the International Society of Pharmacometrics (ISoP) Standards and Best Practices Committee is to provide best practices and recommendations for standard pharmacometric analyses—e.g., population pharmacokinetics/pharmacodynamics (PK/PD), exposure–response, disease models—with the goal of increasing consistency, productivity, quality, communication, and impact of pharmacometrics on decision making. We present the progress and plans of the committee … Continued

Exploratory Modeling and Simulation to Support Development of Motesanib in Asian Patients with Non-small Cell Lung Cancer Based on MONET1 Study Results

The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in non–small cell lung cancer, but a subpopulation of Asian patients had a favorable outcome. We performed exploratory modeling and simulations based on MONET1 data to support further development of motesanib in Asian patients. A model-based estimate of time to tumor … Continued

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The pharmaceutical industry continues to face significant challenges. Very few compounds that enter development reach the marketplace, and the investment required for each success can surpass $1.8 billion. Despite attempts to improve efficiency and increase productivity, total investment continues to rise whereas the output of new medicines declines. With costs increasing exponentially through each development … Continued

A Physiologically-based Pharmacokinetic Modeling Approach to Predict Disease-drug Interactions: Suppression of CYP3A by IL-6

Elevated cytokine levels are known to downregulate expression and suppress activity of cytochrome P450 enzymes (CYPs). Cytokine-modulating therapeutic proteins (TPs) used in the treatment of inflammation or infection could reverse suppression, manifesting as TP-drug-drug interactions (TP-DDIs). A physiologically based pharmacokinetic model was used to quantitatively predict the impact of interleukin-6 (IL-6) on sensitive CYP3A4 substrates. … Continued

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