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Related Concept Videos

Drug Elimination: The Concept of Clearance01:06

Drug Elimination: The Concept of Clearance

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Drug elimination refers to removing drugs from the body, either through urine by the kidneys or through bile by the liver. Drug clearance is a pharmacokinetic parameter that measures the efficiency of drug removal from the bloodstream within a specific time frame. It is calculated as the rate at which a drug is eliminated from plasma divided by the plasma concentration of the drug.
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Drug Clearance: Overview01:06

Drug Clearance: Overview

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Drug elimination refers to drug removal from the body, either through urine or bile, by the kidneys or liver, respectively. A pharmacokinetic parameter, drug clearance, measures the efficiency of drug removal from the bloodstream within a specific time frame. It is calculated as the rate at which a drug is eliminated from plasma divided by the drug's concentration in plasma.
Drug clearance is not limited to renal excretion but encompasses all organs involved in drug elimination, including...
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Drug Elimination: Overview01:18

Drug Elimination: Overview

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Drug elimination involves many complex processes and does not necessarily differentiate between distribution and elimination. It is divided into two primary components: excretion and biotransformation.
Excretion refers to removing a drug from the body, either in its unchanged form or as its metabolites. Nonvolatile and polar drugs are primarily excreted through the kidneys, with other pathways including bile, sweat, saliva, and milk. Volatile drugs such as anesthetic gases are excreted via the...
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Kinetics of Drug Elimination01:17

Kinetics of Drug Elimination

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Eliminating drugs from the body is a vital process that occurs through excretion or metabolism. Understanding the kinetics of drug elimination is crucial for drug development, dosage determination, and optimizing patient outcomes.
Drug clearance depends on the rate of drug elimination and its plasma concentration. Another important parameter is the half-life of a drug, which is the time required for its concentration to decrease by half. In most cases, drug clearance follows first-order...
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One-Compartment Open Model: Urinary Excretion Data and Determination of k01:11

One-Compartment Open Model: Urinary Excretion Data and Determination of k

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The one-compartment open model leverages urinary excretion data to estimate renal clearance, which gauges the kidney's capacity to expel a drug. This method offers several benefits, including directly measuring drug elimination and assessing the kidney's contribution to overall drug clearance. However, this approach has limitations. It assumes sole renal excretion of the drug, which is not true for all drugs. Accurate urinary excretion and plasma drug concentration measurement can also...
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Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance01:23

Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance

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The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
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Related Experiment Video

Updated: Sep 2, 2025

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals
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Understanding Study Drug Discontinuation Through EUCLID.

E Hope Weissler1, Hillary Mulder1, Frank W Rockhold1

  • 1School of Medicine, Duke University, Durham, NC, United States.

Frontiers in Cardiovascular Medicine
|August 5, 2022
PubMed
Summary
This summary is machine-generated.

Premature study drug discontinuation is common in peripheral artery disease (PAD) patients, affecting over a quarter of participants. This discontinuation is linked to worse cardiovascular and limb event outcomes, highlighting the need for proactive trial management.

Keywords:
antiplatelet therapy)clinical trialdisparities (healthperipheral artery disease (PAD)protocol deviation

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Area of Science:

  • Cardiovascular Medicine
  • Clinical Trials
  • Pharmacology

Background:

  • Peripheral artery disease (PAD) care and outcomes exhibit known disparities, partly due to trial enrollment inequalities.
  • Non-random protocol non-adherence, specifically study drug discontinuation, is understudied but impacts treatment effect accuracy and generalizability.
  • Understanding factors leading to premature study drug discontinuation is crucial for improving clinical trial validity in PAD.

Purpose of the Study:

  • To identify patient characteristics associated with premature study drug discontinuation in a peripheral artery disease (PAD) cohort.
  • To assess the relationship between study drug discontinuation and major adverse cardiovascular events (MACE), major adverse limb events (MALE), and hospitalization.

Main Methods:

  • Utilized data from the EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) trial.
  • Employed univariable and multivariable Cox proportional hazards models to analyze factors associated with study drug discontinuation.
  • Assessed the association between discontinuation and MACE, MALE, and all-cause hospitalization.

Main Results:

  • Over a quarter of EUCLID participants (28.1%) prematurely discontinued study drug over a median follow-up of 42 months.
  • Premature discontinuation was associated with older age, specific eligibility criteria (prior lower extremity revascularization), critical limb ischemia (CLI) status, and COPD.
  • Study drug discontinuation significantly correlated with increased risk of MACE (aHR 3.27), MALE (aHR 1.84), and all-cause hospitalization (aHR 2.37).

Conclusions:

  • Premature study drug discontinuation is a common issue in PAD clinical trials, affecting patient characteristics and trial outcomes.
  • Discontinuation is unevenly distributed, influenced by geography and baseline patient factors, potentially compromising cohort representativeness.
  • Prospective strategies to address study drug discontinuation are recommended for future PAD trials to maintain cohort diversity and study power.