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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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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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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The US Food and Drug Administration (FDA) released a new draft guidance on Population Pharmacokinetics (popPK) in July of 2019.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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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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The liver is responsible for the metabolism and clearance of many different drugs and their metabolites. Because of the liver’s importance in removing drugs from the body, diseases or injuries…
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One of the basic tenets of pharmaceutical drug development is the selection of an optimal dose to give to patients. Dose selection is important because too small of a dose…
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