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The newest global pharmacovigilance regulations including the EU’s updated 2025/1466 framework require Marketing Authorisation Holders to continuously monitor EudraVigilance, apply standardized data models (MedDRA, ISO IDMP, HL7), strengthen signal-management documentation, and ensure stricter oversight of subcontracted PV activities. Regulators globally, including the FDA and emerging markets, now expect proactive signal detection, validated safety systems, high-quality ICSR reporting, and timely updates to product information when new signals emerge.
Specialized partners like Atvigilx, known for expert pharmacovigilance consulting services, help companies meet these fast-evolving requirements by implementing compliant signal-detection frameworks, enhancing data quality, and ensuring global regulatory alignment.
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What has the author Iickho Song written?
Iickho Song has written: 'Advanced theory of signal detection' -- subject(s): Signal detection
What is detection of AM?
AM is amplitude modulation. AM detection is the process of demodulation or recovering the information encoded in the signal through amplitude modulation. AM detection can be done through a simple diode detector which rectifies the AM signal.
What is difference between synchronous detection and envelop detection?
Synchronous detection, also known as coherent detection, involves multiplying the incoming signal with a reference signal that is phase-aligned, allowing for accurate recovery of the signal even in the presence of noise. Envelop detection, on the other hand, is a simpler method primarily used for amplitude modulation (AM) signals, where the envelope of the modulated signal is extracted to retrieve the original message. While synchronous detection is more complex and effective in various conditions, envelope detection is easier to implement and is often used in applications where precise phase information is not critical.
What is a signal detection threshold?
Detection theory allows one to quantify the ability to discern between information bearing patterns and random patterns that causes confusion in the patterns. In electronics, detection theory is often called signal recovery.
What has the author Ralph Dieter Hippenstiel written?
Ralph Dieter Hippenstiel has written: 'Detection theory' -- subject(s): Mathematics, Signal processing, Electronic surveillance, Digital techniques, Signal theory (Telecommunication), Detectors, Signal detection
What is the matched filter?
A matched filter is a filter used in signal processing to maximize the signal-to-noise ratio for a known signal in the presence of noise. It is designed by matching the filter characteristics to the shape of the input signal to enhance the detection performance. It is commonly used in radar systems and communication systems for signal detection and recovery.
What theory of perception proposes that detection of stimuli depends on a variety of factors?
Signal Detection Theory proposes that the detection of stimuli depends on both the intensity of the stimulus and the individual's psychological factors, such as motivation and expectancy. This theory suggests that perception is influenced by both the sensitivity of sensory processes and cognitive factors.
'What is the best formula for detection limit?
The best formula for detection limit is usually the limit of detection (LOD) or the limit of quantification (LOQ). These are commonly calculated using the signal-to-noise ratio method, where the limit of detection is three times the standard deviation of the blank signal divided by the slope of the calibration curve, and the limit of quantification is ten times the standard deviation of the blank signal divided by the slope of the calibration curve.
What has the author James P Egan written?
James P. Egan has written: 'Signal detection theory and ROC-analysis' -- subject(s): Decision making, Psychometrics, Psychophysics, Sensation, Signal detection (Psychology)
What does signal detection theory add to the ideas of sensory thresholds?
Signal detection theory adds the idea that decision-making is involved in detecting signals, rather than just relying on sensory thresholds. It also considers factors like motivation, expectation, and experience in detecting and responding to signals, providing a more comprehensive understanding of how we perceive and interpret sensory information.
How is the sensitivity of a signal detection system measured when calculating d'?
The sensitivity of a signal detection system is measured by calculating d', which is a statistical measure that takes into account both the hit rate (correctly detecting a signal) and the false alarm rate (incorrectly detecting a signal). A higher d' value indicates greater sensitivity in distinguishing between signal and noise.
What does signal-detection theory take into account?
Signal detection theory, is a means to quantify the ability to discern between signal and noise. There are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. When the detecting system is a human being, experience, expectations, physiological state (e.g. fatigue) and other factors can affect the threshold applied
