Related Experiment Video
Updated: Feb 6, 2026
12:27
Author Spotlight: Balancing Speed, Cost, and Accuracy in Neutrophil Function Assessment with NeutroFun Screen Protocol
Published on: February 9, 2024
3.8K
Pharmacovigilance: An Overview
1Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
Clinical Therapeutics
|August 22, 2018
Summary
Pharmacovigilance (PV) has rapidly evolved, encompassing drug safety monitoring, clinical trial support, and post-marketing surveillance. Future advancements in AI and machine learning will reshape PV professional skill sets for enhanced pharmaceutical safety.
Area of Science:
- Pharmacovigilance (PV) in the pharmaceutical industry.
- Drug safety and risk management.
- Regulatory affairs and compliance.
Background:
- PV emerged in the 1950s due to concerns over chloramphenicol's side effects.
- Formalized by the 1962 Kefauver-Harris Amendments, establishing adverse event reporting.
- Core functions include case, signal, and benefit-risk management.
Purpose of the Study:
- To provide insights into the background and inner workings of pharmacovigilance.
- To review core PV activities and their contributions to the pharmaceutical enterprise.
Main Methods:
- This is a narrative review.
- Covers core PV activities and contributions across the pharmaceutical enterprise.
Main Results:
- PV has expanded to include clinical trial safety, dose selection, safety profile development, signal surveillance, manufacturing monitoring, post-marketing benefit-risk management, and inspection readiness.
- Historical context traces PV's development from early drug safety concerns to current comprehensive functions.
Conclusions:
- The integration of informatics, AI, and machine learning will accelerate PV evolution.
- Future PV professionals require new skill sets to drive pharmaceutical safety improvements.
Related Concept Videos
01:19Pharmacovigilance
1.8K
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...
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...
1.8K
01:40Overview of Metabolism
38.5K
Living cells constantly carry out various chemical reactions which are necessary for their proper functioning. These reactions are interlinked to one another via multiple pathways. The collection of these chemical reactions is known as metabolism.
Plant Metabolism
Sunlight, the primary source of energy in plants, is first absorbed by the chlorophyll pigments present in their leaves. Plants then use this energy to carry out photosynthesis, where water is oxidized into oxygen and carbon dioxide...
Plant Metabolism
Sunlight, the primary source of energy in plants, is first absorbed by the chlorophyll pigments present in their leaves. Plants then use this energy to carry out photosynthesis, where water is oxidized into oxygen and carbon dioxide...
38.5K
01:19Overview of Functional Groups
16.3K
Functional groups are a group of atoms with characteristic properties, which when linked to the carbon skeleton of a molecule, alter the properties of that molecule. For example, certain functional groups will make a molecule hydrophilic, whereas others will make them hydrophobic. These functional groups are an indispensable part of organic chemistry and important components of biological molecules, such as carbohydrates, proteins, lipids, and nucleic acids. Each functional group is a unique...
16.3K
01:10Pharmacokinetics: Overview
9.6K
Pharmacokinetics is a scientific discipline that focuses on the journey of a drug within the body, encompassing four key stages: absorption, distribution, metabolism, and elimination. The first stage, absorption, involves the drug's transfer into the bloodstream. Several factors dictate the extent and speed of this process. For example, the liver often metabolizes oral drugs before they reach systemic circulation, leading to only partial absorption. In contrast, intravenous (IV)...
9.6K
01:13Bioavailability: Overview
4.5K
Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
4.5K
00:59Uncertainty: Overview
1.7K
In analytical chemistry, we often perform repetitive measurements to detect and minimize inaccuracies caused by both determinate and indeterminate errors. Despite the cares we take, the presence of random errors means that repeated measurements almost never have exactly the same magnitude. The collective difference between these measurements - observed values - and the estimated or expected value is called uncertainty. Uncertainty is conventionally written after the estimated or expected value.
1.7K