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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Personalized medicine (also known as precision medicine) is one of today’s biggest drug development buzzwords. It certainly stirs the imagination – the notion that one day we may live in…
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A topically applied drug is any medication that is applied to the body’s surface (e.g., skin, eyes) in order to achieve a desired local therapeutic effect. Many drug types fall under…
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Population pharmacokinetics (popPK) is the study of variability in drug concentrations within a patient population receiving clinically relevant doses of a drug of interest. PopPK methods use mathematical models to describe…
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Modeling and simulation are transforming how drugs are developed and how they are regulated. This is the conclusion from a recent FDA Grand Rounds presentation entitled “How Simulation can Transform…
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