(Download) "Signal Detection & Management" by Pro Career # Book PDF Kindle ePub Free
eBook details
- Title: Signal Detection & Management
- Author : Pro Career
- Release Date : January 23, 2020
- Genre: Education,Books,Professional & Technical,Medical,Pharmacology & Toxicology,
- Pages : * pages
- Size : 418 KB
Description
Signals from spontaneous reports may be detected from ICSRs, literature, PBRERs and information from regulatory documents such as variations, renewals, and risk-benefit plans. Poison centers, teratology information services or vaccine surveillance programs also contribute ICSRs in addition to reports from consumers and HCPs.
Statistical algorithms are applied to this structured dataset to calculate measures of association. If the statistical measure crosses a set threshold, then it is considered to be a signal. Signals are typically generated in drug-event pairs - an adverse event associated with a particular drug. Signals which are significant require further analysis using all available data either to confirm or refute the signal.
Signals detected via the monitoring of EudraVigilance should be handled in a specific manner.
Not all disproportionate reporting have to be further investigated as signals and conversely, some drug-event combinations that do not appear as disproportionate reporting may need further investigation.
Signal Detection & Management Process with GVP , EMEA and FDA guidelines.
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