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Related Concept Videos

Lipid-Lowering Drugs: Statins and Miscellaneous Agents01:20

Lipid-Lowering Drugs: Statins and Miscellaneous Agents

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Hyperlipidemia, a medical condition often referred to as high cholesterol, is characterized by abnormally elevated levels of lipids in the bloodstream. When present in excess, these lipids, specifically cholesterol and triglycerides, can lead to serious health complications, often involving cardiovascular diseases. Illnesses like atherosclerosis, heart attacks, and pancreatitis have all been linked to untreated hyperlipidemia. This means controlling and regulating cholesterol and triglyceride...
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Atherosclerosis III: Management01:26

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Management of atherosclerosis involves an integrated strategy encompassing pharmacological treatment, surgical interventions, lifestyle changes, and nutrition therapy to address the multifactorial nature of the disease.Pharmacological TherapyA cornerstone of atherosclerosis management is the use of pharmacological agents. Statins, such as atorvastatin, are pivotal in inhibiting HMG-CoA reductase, an enzyme that catalyzes an initial step in cholesterol synthesis in the liver. This reduction in...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Cholesterol: Significance and Regulation01:29

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Although not a source of energy, cholesterol plays a significant role as a foundational structure for bile salts, steroid hormones, and vitamin D, as well as being a crucial component of plasma membranes. Approximately 15% of blood cholesterol is derived from our diet, with the remainder synthesized from acetyl CoA by the liver and intestines. Cholesterol is eliminated from the body through its conversion into bile salts, which are eventually discarded in the feces.
Considering cholesterol and...
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Therapeutic Drug Monitoring: Overview and Classification01:16

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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Overview of Lipid Metabolism01:24

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Lipid metabolism is a crucial process in the human body that involves the synthesis and degradation of lipids. This process is essential for energy production, cell membrane formation, and hormone production, among other functions.
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Related Experiment Video

Updated: May 6, 2026

Differential Effects of Lipid-lowering Drugs in Modulating Morphology of Cholesterol Particles
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New statin labeling requirements: an overview.

Megan R Hicks1, Bethany L Murphy

  • 1School of Pharmacy, Union University, Jackson, Tennessee.

The Consultant Pharmacist : the Journal of the American Society of Consultant Pharmacists
|November 13, 2013
PubMed
Summary

New FDA labeling requirements for statins, including hepatic dysfunction and cognitive impairment, are now in effect. Pharmacists play a key role in informing patients and providers about these important medication safety updates.

Keywords:
AST/ALT = AminotransferasesCV = CardiovascularCardiovascularCognitive impairmentElderlyFDA = Food and Drug AdministrationFPG = Fasting plasma glucoseFasting plasma glucoseFood and Drug AdministrationHMG-CoA reductase inhibitorsLFTs = Liver function testsLabeling changesLabeling requirementsLiver function testsPharmacistStatins

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LDL Cholesterol Uptake Assay Using Live Cell Imaging Analysis with Cell Health Monitoring
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Area of Science:

  • Pharmacology and Therapeutics
  • Drug Safety and Regulation

Background:

  • Pharmacists advocate for safe and effective medication use.
  • Medication labeling is crucial for patient safety, especially when initiating or changing therapies.

Purpose of the Study:

  • To inform pharmacists about new mandatory labeling requirements for statins.
  • To highlight the importance of these updates for patient safety and medication management.

Main Methods:

  • Review of Food and Drug Administration (FDA) announcements.
  • Analysis of studies, adverse-event reporting databases, and literature reviews informing the labeling changes.

Main Results:

  • New labeling requirements for HMG-CoA reductase inhibitors (statins) were released in early 2012.
  • These requirements address hepatic dysfunction, cognitive impairment, and glycemic control associated with statin use.

Conclusions:

  • Pharmacists must be prepared to educate patients and healthcare providers on the new statin labeling.
  • Pharmacists can play a vital role in managing statin therapy based on updated safety information.