PK/PD Modeling & Simulation

Using Modeling and Simulation to Support Approvals for Orphan Drugs

Suzanne Minton

Rare diseases affect fewer than 1 in 2000 people. Each one affects only a small number of patients. Yet, there are over 7000 rare diseases. And, there are no treatments for 95 percent of them. Thus, many patients suffer from these diseases. The treatments for rare diseases are often referred to as “orphan drugs.” Orphan […]

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Topics: PK/PD Modeling & Simulation

How Modeling and Simulation Technology Could Save Us from the Zombie Apocalypse

Martin Beliveau

Skeptical at the idea of ravenous brain-eating undead? You don’t have to take my word for it. The Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response recognizes this threat. Their Zombie Preparedness website provides information on getting ready for all kinds of disasters. Modeling and simulation (M&S) technology can […]

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Topics: PK/PD Modeling & Simulation

Analyzing Complex In Vitro Experiments: It’s Not as Hard as You Think

Krishna Machavaram

Analyzing in vitro experiments can be challenging and time consuming. Yet, crucial decisions depend on accurate data analysis and interpretation early in development. Unfortunately, most lab-based scientists lack access to state-of-the-art models for analyzing in vitro data. A new tool enables the analysis of data generated from complexin vitro studies. These studies include assays using […]

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Topics: Model-based Meta-analysis, PK/PD Modeling & Simulation

Is Your Approach to Regulatory Writing the Elephant in the Room?

Steve Sibley

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this: A group of blind men hear that an elephant has arrived in their village. Being blind, […]

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Topics: Regulatory & Medical Writing