Scientific Literature Monitoring for Drug Safety Signals

Impact of literature reports on drug safety signals - PMC

Signal management is considered an important activity in pharmacovigilance and should be performed using any available source of data, including scientific ...

Scientific Literature Monitoring for Drug Safety Signals - Ontotext

Ontotext provides a highly configurable and flexible solution for scientific literature monitoring of adverse events.

Pharmacovigilance: Literature Monitoring Best Practices

Pharmacovigilance aims to identify, detect, assess, and report any adverse drug reaction (ADR) related to pharmaceutical products. In the United ...

Methods for drug safety signal detection using routinely collected ...

Signal detection is a crucial step in the discovery of post‐marketing adverse drug reactions. There is a growing interest in using routinely collected data to ...

Dialog Pharmacovigilance Literature Monitoring - Clarivate

Our pharmacovigilance (PV) literature monitoring solution gives any organization tasked with drug safety reporting a streamlined, efficient and compliant ...

EVIDEX® Signal Detection - TriNetX

Once a drug is on the market, it will quickly amass individual case safety reports (ICSRs). It is not feasible to review the contents of each report for the ...

Drug Safety Triager Software | Clarivate

It makes the drug safety literature monitoring process more efficient, cost-effective and compliant. Our customers range from the top 10 global pharmaceutical ...

Signal Detection in Pharmacovigilance: A Review of Informatics ...

Drug safety monitoring identified as Pharmacovigilance (PV) is formally defined by the “World Health Organization (WHO)” as “the science and activities relating ...

Characterization and corroboration of safety signals identified from ...

4 Also, in 2008, the FDA launched the Sentinel Initiative, an active surveillance system intended to complement the FAERS to assess the safety ...

Impact of literature reports on drug safety signals

Signal detection should be performed using any available source of data, including data from the scientific literature [1]. 188. Impact of ...

Safety signal | European Medicines Agency (EMA)

Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ...

An MCEM Framework for Drug Safety Signal Detection and ... - Nature

Delayed drug safety insights can impact patients, pharmaceutical companies, and the whole society. Post-market drug safety surveillance ...

Impact of literature reports on drug safety signals - ResearchGate

Most literature ICSRs from this analysis were created based on scientific journals indexed in bibliographic databases; therefore, it can be ...

Potential Signals of Serious Risks/New Safety Information Identified ...

If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions, including requiring ...

[PDF] Safety Signal Detection: The Relevance of Literature Review

The requirements of the new pharmacovigilance guidelines on literature screening are analyzed and the need for the implementation of a literature review ...

Navigating the Dynamics of Literature Surveillance - LinkedIn

Literature surveillance is a foundational component of pharmacovigilance, playing a critical role in identifying and assessing adverse drug reactions and ...

Impact of literature reports on drug safety signals - springermedizin.at

Most literature ICSRs from this analysis were created based on scientific journals indexed in bibliographic databases; therefore, it can be ...

Signal management | European Medicines Agency (EMA)

Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The ...

Detection of drug safety signals from clinical trials data

Safety surveillance during clinical trials firstly aims to detect Suspected Unexpected Serious Adverse Drug Reactions (SUSARs). · SUSARs are conceptually similar ...

The Reporting of a Disproportionality Analysis for Drug Safety Signal ...

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug ...