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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the appropriate...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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...
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...

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Why there is a need for pharmacovigilance.

W K Amery1,

  • 1Pharmaco-epidemiology and Medical Evaluation, Janssen Research Foundation, Beerse, Belgium.

Pharmacoepidemiology and Drug Safety
|April 10, 2004
PubMed
Summary

Post-marketing surveillance is crucial because clinical trials often miss drug side effects. Rare, context-specific, or hard-to-detect adverse events require real-world data for full understanding.

Area of Science:

  • Pharmacovigilance
  • Clinical Trial Methodology
  • Drug Safety

Background:

  • Medicinal product approval relies on balancing benefits and risks.
  • Real-world drug usage provides essential data beyond clinical trials.
  • Phase III clinical trials have limitations in detecting all adverse events.

Purpose of the Study:

  • To investigate the reasons why phase III clinical trials fail to detect certain drug side effects.
  • To elucidate the mechanisms behind undetected adverse events in pharmaceutical research.

Main Methods:

  • Analysis of limitations in phase III clinical trial design and execution.
  • Identification of factors contributing to the underreporting or non-detection of side effects.
  • Review of existing methodologies for adverse event detection.

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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

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Main Results:

  • Clinical trials may lack statistical power to identify rare adverse events.
  • Certain side effects manifest only in specific real-world contexts not replicated in trials.
  • Inadequate detection techniques can lead to underestimation of common side effects.

Conclusions:

  • Post-marketing surveillance is vital for comprehensive drug safety assessment.
  • Addressing trial limitations requires enhanced methodologies for detecting all drug-related adverse events.
  • Understanding these detection gaps improves future drug safety monitoring.