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Related Concept Videos

Renal Failure: Dose Adjustments01:11

Renal Failure: Dose Adjustments

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In patients with renal impairment, drugs undergo significant changes in their pharmacokinetics, which require dosage adjustments to ensure safe and effective therapy.
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
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Pharmacokinetics: Drug–Drug Interactions01:25

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Drug interactions occur when the pharmacological effect of one drug is altered by another substance, either enhancing or diminishing its activity. The drug whose activity is altered is known as the object drug, and the substance causing the alteration is called the agent drug or the precipitant. The net effects of these interactions are mostly undesirable, leading to decreased effectiveness or increased adverse effects. In rare cases, interactions can be beneficial, such as the enhanced...
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Drug Dosage Regimen: Overview01:15

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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Hepatic Drug Clearance: Restrictive and Nonrestrictive Clearance01:09

Hepatic Drug Clearance: Restrictive and Nonrestrictive Clearance

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Hepatic clearance refers to the volume of blood cleared of a drug by the liver per unit of time. It plays a crucial role in drug metabolism and elimination. While hepatic clearance is commonly estimated by subtracting renal clearance from total body clearance, other pathways, such as pulmonary or biliary clearance, may also contribute. However, these pathways are generally less significant than hepatic and renal clearance.
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Methods for Studying the Mechanisms of Action of Antipsychotic Drugs in Caenorhabditis elegans
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The curious constraints on clofazimine.

Maple Goh1,2,3, Daniel Eisenkraft Klein1, Aaron S Kesselheim1

  • 1Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, 1620 Tremont, Suite 3030, Boston, MA 02120, USA.

The Journal of Antimicrobial Chemotherapy
|November 19, 2025
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Summary
This summary is machine-generated.

Clofazimine, vital for leprosy and other mycobacterial infections, faces access barriers in the USA. New policies are needed for equitable and sustainable access to this essential medicine.

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Area of Science:

  • Pharmacology and Public Health
  • Global Health Policy

Background:

  • Clofazimine is a WHO-recommended treatment for multibacillary leprosy.
  • It is also an emerging option for drug-resistant tuberculosis and non-tuberculous mycobacterial infections.
  • Despite decades of safe use, access in high-income countries like the USA is restricted.

Purpose of the Study:

  • To examine clofazimine's regulatory history in the USA.
  • To contrast global access models for clofazimine.
  • To highlight issues with single-manufacturer reliance and donation programs.

Main Methods:

  • Review of regulatory pathways.
  • Comparative analysis of global access strategies.
  • Assessment of supply chain vulnerabilities.

Main Results:

  • Current systems in the USA present limitations to equitable access.
  • Reliance on a single manufacturer and informal donations creates supply instability.
  • Existing access models are often ill-suited for low-profit essential medicines.

Conclusions:

  • Policy reforms are necessary to ensure sustainable and equitable clofazimine access.
  • Recommendations include simplified access, WHO-based procurement, and public manufacturing.
  • Proactive stewardship is crucial for essential medicines with limited commercial viability.