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

Pharmacovigilance01:19

Pharmacovigilance

1.4K
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...
1.4K
Drug Regulation01:25

Drug Regulation

2.5K
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...
2.5K
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

84
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,...
84
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

88
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.
88
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

112
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...
112
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

973
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
973

You might also read

Related Articles

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

Sort by
Same author

Therapeutic drug monitoring of letermovir in allogeneic hematopoietic cell transplant recipients: where are we?

Expert opinion on drug metabolism & toxicology·2026
Same author

Effects of Extracorporeal Membrane Oxygenation Circuits on Drug Sequestration: A Review of Ex Vivo Experiments.

Journal of clinical medicine·2025
Same author

Population Pharmacokinetics of Levosimendan and its Metabolites OR-1855 and OR-1896 in Critically Ill Adults, Neonates and Infants on Veno-Arterial ECMO.

Clinical pharmacokinetics·2025
Same author

Population Pharmacokinetics of Propofol in Critically Ill Patients with and Without Extracorporeal Membrane Oxygenation.

Clinical pharmacokinetics·2025
Same author

Pharmacokinetics of levosimendan in critically Ill children on extracorporeal membrane oxygenation: a prospective observational study.

Frontiers in pediatrics·2025
Same author

Population pharmacokinetics of bictegravir in real-world people with HIV.

The Journal of antimicrobial chemotherapy·2025

Related Experiment Video

Updated: Nov 21, 2025

Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
09:18

Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study

Published on: March 31, 2022

2.9K

[Pharmacovigilance update].

Pierre Ekobena1, Anton Ivanyuk1, Françoise Livio1

  • 1Service de pharmacologie clinique, Département des laboratoires, CHUV, 1011 Lausanne.

Revue Medicale Suisse
|January 14, 2021
PubMed
Summary

Key 2020 pharmacovigilance updates highlight drug safety concerns. COVID-19 treatments like remdesivir and hydroxychloroquine showed limited efficacy and risks, while other drugs faced withdrawals due to serious adverse events.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Regulatory Science

Background:

  • The year 2020 presented significant pharmacovigilance challenges, particularly concerning novel treatments for COVID-19 and ongoing safety assessments of established medications.
  • Several drug safety issues emerged, necessitating regulatory action and impacting clinical practice.

Purpose of the Study:

  • To review and summarize the most critical pharmacovigilance updates and drug safety concerns reported in 2020.
  • To provide insights into emerging risks associated with various therapeutic agents, including those used for COVID-19.

Main Methods:

  • Systematic review of pharmacovigilance data and regulatory communications from 2020.
  • Analysis of reported adverse events, efficacy data, and market actions for key drugs.

More Related Videos

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
10:02

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs

Published on: July 23, 2016

32.8K
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

13.2K

Related Experiment Videos

Last Updated: Nov 21, 2025

Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
09:18

Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study

Published on: March 31, 2022

2.9K
Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
10:02

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs

Published on: July 23, 2016

32.8K
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

13.2K

Main Results:

  • COVID-19 treatments: Remdesivir demonstrated limited efficacy, while hydroxychloroquine showed lack of efficacy and increased arrhythmia risk.
  • Other drug safety issues: VEGF inhibitors posed risks of aneurysm and artery dissection; Tofacitinib showed a dose-dependent risk of venous thromboembolic events.
  • Market withdrawals: Ranitidine (nitrosamine contamination), Ulipristal (liver injury), and Ingenol mebutate (skin cancers) were withdrawn from the market.
  • Pregnancy-related concerns: Ondansetron use in early pregnancy debated for orofacial cleft defects; Fingolimod contraindicated due to suspected teratogenicity.

Conclusions:

  • 2020 pharmacovigilance highlighted significant safety concerns across various drug classes, impacting both novel and established therapies.
  • Regulatory actions, including market withdrawals and revised usage guidelines, underscore the dynamic nature of drug safety monitoring and management.