Common Misconceptions About QSP Modeling
As Quantitative Systems Pharmacology (QSP) modeling is a relatively new field, there are some common misconceptions that have been brought to our attention. We would like to dispel or provide…
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Cost-Effective Techniques for Creating QSP Models
Quantitative systems pharmacology (QSP) modeling can be an effective tool to solve a variety of drug development questions including understanding a drug’s mechanism of action, determining a drug’s biomarkers, and…
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PBPK Modeling & Simulation in Drug Development
What is PBPK Modeling & Simulation? Physiological based pharmacokinetic modeling and simulation (PBPK) is a computer modeling approach that incorporates blood flow and tissue composition of organs to define the…
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How to Avoid Clinical Trials Using Modeling & Simulation
With modeling and simulation, data can be leveraged to provide important insights on product safety and effectiveness. Modeling and simulation can offer a better understanding of existing clinical trial data…
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Benefits & Uses of QSP in Drug Development
Quantitative systems pharmacology (QSP) is an exciting and powerful convergence of biological pathways, pharmacology, and mathematical models for drug development. QSP has the potential for delivering significant impact to modern…
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FDA Recently Revised the 1999 Population Pharmacokinetic Guidance
The US Food and Drug Administration (FDA) released a new draft guidance on Population Pharmacokinetics (popPK) in July of 2019. The original popPK guidance was published in 1999, making it…
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What is a Human Mass Balance Study?
A human mass balance clinical study aims to understand how drugs are absorbed, metabolized, and excreted after dosing. This information is important because it helps determine other clinical investigations that…
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