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

1.6K
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...
1.6K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Drug Regulation01:25

Drug Regulation

2.7K
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...
2.7K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
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...
1.1K
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

3.2K
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...
3.2K
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K

You might also read

Related Articles

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

Sort by
Same author

Posterior Sternoclavicular Joint Dislocation in a Pediatric Wrestler: Delayed Diagnosis After Initially Benign Radiographs.

Cureus·2026
Same author

Retrospective study of minimally invasive percutaneous ultrasonic tenotomy for chronic patellar tendinosis.

BMC musculoskeletal disorders·2026
Same author

The Sydney Triage to Admission Risk Tool With Artificial Intelligence (START-AI): Prediction of Inpatient Admission From Emergency Departments Using Ensemble Machine Learning.

Emergency medicine Australasia : EMA·2026
Same author

Hand Hygiene Practices in School Populations: Assessing Their Impact on Infectious Disease Outbreaks.

Journal of paediatrics and child health·2026
Same author

Subacute High-Grade Ulnar Neuropathy Without Trauma: A Case of Cubital Tunnel Syndrome.

Cureus·2026
Same author

Dual Antiplatelet Therapy beyond 1 Year after a Myocardial Infarction Compared with Low-Dose Aspirin Alone: A 3-Year Follow-Up Cohort Study Within the French SNDS Nationwide Claims Database.

American journal of cardiovascular drugs : drugs, devices, and other interventions·2026
Same journal

Pharmacology of pruritus (pathophysiology, therapeutic targets).

Therapie·2026
Same journal

Barriers to prescribing methylphenidate for adults with ADHD: A qualitative study.

Therapie·2026
Same journal

[Self-medication and its factors amongst Navymen aboard surface ships of the French Navy at sea: A descriptive study].

Therapie·2026
Same journal

Subacute cutaneous lupus erythematosus induced by ticagrelor: Recurrence after rechallenge.

Therapie·2026
Same journal

Multiple HIV virological failures related to bictegravir-valproic acid interaction evidenced by therapeutic drug monitoring: A retrospective study.

Therapie·2026
Same journal

Indication-related misuse of oral fluoroquinolones in adults by general practitioners in France.

Therapie·2026
See all related articles

Related Experiment Video

Updated: Jan 5, 2026

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

3.0K

Pharmacovigilance - The next chapter.

Nicholas Moore1, Driss Berdaï2, Patrick Blin1

  • 1Inserm CIC1401, Bordeaux PharmacoEpi, université de Bordeaux, 33076 Bordeaux, France.

Therapie
|October 19, 2019
PubMed
Summary
This summary is machine-generated.

Spontaneous reporting remains crucial for discovering adverse drug reactions and generating safety signals. However, for precise risk quantification, especially for serious events, population-wide databases like electronic health records are essential.

Keywords:
Drug safetyPharmacoepidemiologyPharmacovigilancePopulation databases

More Related Videos

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.3K
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

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

Published on: December 1, 2020

5.4K

Related Experiment Videos

Last Updated: Jan 5, 2026

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

3.0K
Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.3K
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

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

Published on: December 1, 2020

5.4K

Area of Science:

  • Pharmacovigilance
  • Pharmacoepidemiology
  • Drug Safety

Background:

  • Spontaneous reporting systems have historically been vital for identifying adverse drug reactions (ADRs).
  • Causality assessment and disproportionality analyses in spontaneous reports have led to new drug information and market withdrawals.
  • However, risk quantification using spontaneous reports presents inherent uncertainties.

Purpose of the Study:

  • To evaluate the role of spontaneous reporting in drug safety signal generation and risk quantification.
  • To explore the complementary utility of population-wide databases for ADR assessment.

Main Methods:

  • Analysis of spontaneous adverse drug reaction reports.
  • Leveraging population-wide claims or electronic health records databases.
  • Application of pharmacoepidemiological methods for quantitative analysis.

Main Results:

  • Spontaneous reporting remains indispensable for generating signals and alerts for ADRs.
  • Population-wide databases confirm spontaneous reporting's role in hypothesis generation for serious ADRs (e.g., hospital admission, death).
  • These databases enable precise quantification and benefit-risk analyses for severe events.

Conclusions:

  • Spontaneous reporting is irreplaceable for initial signal detection in pharmacovigilance.
  • Population-wide databases offer superior quantitative capabilities for serious ADRs, complementing spontaneous reporting.
  • Systematic and quantitative methods, including claims databases, are needed for robust signal strengthening and assessment.