In this concise blog, we discuss:
- The fundamentals of databases
- The emergence of pharmacovigilance databases
- The evolutionary stages of database development in pharmacovigilance.
Table of Contents:
- Introduction
- The Emergence of Pharmacovigilance Databases
- Historical Evolution of Pharmacovigilance database
- Recommendation
- Summary of Invention
- Thoughts
- References
Introduction
Pharmacovigilance databases are repositories that store and maintain all the information about drugs, which extracted from clinical studies. These databases design to track those records over extended periods and must be regularly submitted to regulatory authorities for review.
The Emergence of Pharmacovigilance Databases
The emergence of adverse event databases to reduce the complexity in validating potential data. With variable structures and terminology has led to difficulties in querying.
And,
Also, data corruption in databases such as the FDA’s SRS and AERS has been acknowledged but not quantified.
To address these challenges, the invention of a pharmacovigilance database emerged. This development of database improves quality and clarity in parsing source data, Perform data cleanup, to ease follow-up, submission and transparency in the pharmaceutical field.
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Historical Evolution of Pharmacovigilance database
The September 1997 Incident and Its Impact on FDA’s Rethinking of Drug Submission. The incident which related to the drug fenfluramine and phentermine (“fen-phen”) used for cardiopulmonary disease.
This led to the creation of the Spontaneous Reporting System (SRS), a pharmacovigilance database that contains adverse drug reaction reports from various sources.
However, the SRS is not a structured database that is amenable to typical query. To address this issue, the FDA implemented the Adverse Event Reporting System (AERS), a non-cumulative database of post-market drug adverse events.
The aim is that various organizations, including pharmaceutical companies and hospitals, also track adverse drug effects, often using unique database structures, which presents an obstacle to efficient use of potentially valuable data.
So this is the continuous in development what we are using now.
Summary of invention
The present invention addresses the limitations of existing adverse event databases and introduces several advantageous features.
It involves a method for developing a pharmacovigilance database by parsing and cleaning up source data, mapping verbatim terms to reference data, and standardizing historical terms.
The resulting database provides high-quality data for risk assessors, pharmaceutical industry personnel, marketing and sales personnel, research and development personnel, regulators, and the public.
The invention aims to integrate disparate databases, mitigate data corruption, and use canonical terms for efficient query and meaningful statistical comparisons.
Thoughts
Innovation and inventions are continuously evolving, just like that also development happens with the development of pharmacovigilance monitoring databases, which are advancing with more sophisticated reporting methods every day.
While we currently lack crucial references to collect more information, we rely on the references we have to gather all this data, and we’ll continue updating it with new findings.
Feel free to share your thoughts.
References
- Bibliography: Gogolak, V., 2004. Pharmacovigilance database. US6778994B2.
- Evolution of PV database
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