Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Regulation01:25

Drug Regulation

1.4K
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...
1.4K
Pharmacovigilance01:19

Pharmacovigilance

821
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...
821
Drug Dosage Regimen: Overview01:15

Drug Dosage Regimen: Overview

3.5K
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.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
3.5K
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

719
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
719
Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance01:23

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

120
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...
120
Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

1.9K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
1.9K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Anti-HER2, High-DAR Antibody Fragment-Drug Conjugates with a Glucuronide-Based MMAE Linker-Payload Demonstrate Superior Efficacy over IgG-Based ADCs.

Molecular cancer therapeutics·2025
Same author

The Cryptosporidium signaling kinase CDPK5 plays an important role in male gametogenesis and parasite virulence.

Cell reports·2024
Same author

Responsibility as an Ethics and Sustainability Element during the Pandemic.

Behavioral sciences (Basel, Switzerland)·2023
Same author

Analysis of Sustainable Communication Patterns during the Telework Period in Western Romanian Corporations.

International journal of environmental research and public health·2022
Same author

Disorder is a critical component of lipoprotein sorting in Gram-negative bacteria.

Nature chemical biology·2021
Same author

Modified headspace solid-phase microextraction for the determination of quantitative relationships between components of mixtures consisting of alcohols, esters, and ethers - impact of the vapor pressure difference of the compounds.

Journal of separation science·2017

Related Experiment Video

Updated: Jun 23, 2025

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
11:17

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

12.9K

Overdosage Section in US and EU Labeling.

Sarah Condon1, Thomas G Cantu2, Antony Constantinou3

  • 1GSK, London, UK. sarah.8.condon@gsk.com.

Therapeutic Innovation & Regulatory Science
|June 17, 2024
PubMed
Summary

This study reviewed US and EU drug labeling overdosage information, finding it generally compliant but lacking details on clinical overdose data and risk factors. Enhanced regulatory guidance could improve usefulness for healthcare professionals.

Keywords:
LabelingOverdosageRegulatory AffairsSafety

More Related Videos

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.6K
Color Spot Test As a Presumptive Tool for the Rapid Detection of Synthetic Cathinones
06:06

Color Spot Test As a Presumptive Tool for the Rapid Detection of Synthetic Cathinones

Published on: February 5, 2018

24.7K

Related Experiment Videos

Last Updated: Jun 23, 2025

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
11:17

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

12.9K
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.6K
Color Spot Test As a Presumptive Tool for the Rapid Detection of Synthetic Cathinones
06:06

Color Spot Test As a Presumptive Tool for the Rapid Detection of Synthetic Cathinones

Published on: February 5, 2018

24.7K

Area of Science:

  • Regulatory Science
  • Pharmacovigilance
  • Drug Labeling

Background:

  • Prescribing Information (PI) and Summary of Product Characteristics (SmPC) are regulatory documents for drug overdosage information in the US and EU.
  • Compliance with overdosage information is a regulatory requirement in both regions.

Purpose of the Study:

  • To evaluate the content of the overdosage sections in US and EU drug labeling.
  • To identify areas for improved regulatory guidance.

Main Methods:

  • Analysis of overdosage sections from US drug labels (2000-2021) and corresponding EU labels (Centralized Procedure).
  • Data collection and analysis using a predefined questionnaire focused on regulatory adherence.

Main Results:

  • Overdosage sections largely comply with regional regulatory requirements.
  • Less than half of labels included supratherapeutic dose data, risk factors, or population-specific overdose information.
  • Inconsistencies noted regarding animal vs. human data and Poison Center references.

Conclusions:

  • While generally compliant, overdosage labeling could be enhanced with more specific clinical data and consistent presentation.
  • Additional regulatory guidance is recommended to improve the utility of this information for healthcare professionals.