Pharmacovigilance
Principles: The Building Blocks of Benefit-Risk Assessment Open
Access
Rosa A. Piccirillo, MD and Jennifer Parish, MD MPH
October
17, 2022
DOI: 10.36316/gcatr.04.0045.
Abstract
A
medicinal product must demonstrate a favorable benefit-risk balance to remain
on the market. That the benefits of use outweigh the risks is established using
analyses referred to as benefit-risk assessments, which are conducted on
an ongoing basis throughout the lifecycle of a medicinal product. While
fundamental to maintaining a product’s marketing authorization, few regulatory
guidance documents have been developed to provide information on the specific
content and structure of a benefit-risk assessment. This paper aims to provide
an overview of the key concepts in pharmacovigilance that contribute to the
creation of a structured benefit-risk assessment, particularly through
qualitative analysis.
Keywords
Pharmacovigilance;
Benefit-risk assessments; Drug safety profile
Copyright©2022 by the author(s). Licensee Global
Clinical and Translational Research. This is an open-access article
distributed under the terms and conditions of the Creative Commons Attribution
License (CCBY4.0, https://creative-commons,org/license/by/4.0/),
which permits unrestricted use, distribution, and reproduction in any medium
provided the original work is properly cited.
How to cite this article. Piccirillo R and Parish J. Pharmacovigilance Principles: The Building
Blocks of Benefit-Risk Assessments. Glob Clin Transl Res. 2022; 4(4): 1-7.
DOI:10.36316/gcatr.04.0045.
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