Tag: LOD LOQ biomarkers

Passive vs Active Surveillance Strategies for Post-Marketing Vaccine Safety

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Passive vs Active Surveillance Strategies for Post-Marketing Vaccine Safety Choosing Between Passive and Active Surveillance in Post-Marketing Vaccine Safety Passive vs Active Surveillance—What They Are and When to Use Each Passive surveillance collects Individual Case Safety Reports (ICSRs) from clinicians, patients, and manufacturers via national systems (e.g., VAERS/EudraVigilance analogs). It excels at early pattern recognition…

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Post-Marketing Surveillance, Vaccine Clinical Trials

Pharmacovigilance for COVID-19 and Future Vaccines: Methods, Thresholds, and Inspection-Ready Documentation

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Pharmacovigilance for COVID-19 and Future Vaccines: Methods, Thresholds, and Inspection-Ready Documentation Pharmacovigilance for COVID-19 and Future Vaccines Build the Right Pharmacovigilance Architecture: From Intake to Evidence You Can Defend Post-marketing pharmacovigilance (PV) for COVID-19 vaccines—and for whatever comes next—requires a layered system that converts raw reports into defensible evidence. Start with intake and case processing…

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Post-Marketing Surveillance, Vaccine Clinical Trials

Surveillance of Rare Adverse Events Post-Vaccination

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Surveillance of Rare Adverse Events Post-Vaccination Surveillance of Rare Adverse Events Post-Vaccination Why rare-event surveillance matters—and what a regulator expects to see Licensure is not the end of safety work; it marks the start of population-scale learning. Pre-licensure studies are typically underpowered for events occurring at 1–10 per million doses (e.g., anaphylaxis, myocarditis, thrombosis with…

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Post-Marketing Surveillance, Vaccine Clinical Trials

Surveillance of Rare Adverse Events Post-Vaccination

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Surveillance of Rare Adverse Events Post-Vaccination How to Monitor Rare Adverse Events After Vaccination Why Rare-Event Surveillance Matters and What Regulators Expect Licensure is not the finish line for safety; it is the start of population-scale learning. Even very large pre-licensure trials are underpowered for events with true incidences of 1–10 per million doses (e.g.,…

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Post-Marketing Surveillance, Vaccine Clinical Trials

Steps in Developing a Biomarker Validation Plan

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Steps in Developing a Biomarker Validation Plan Designing an Effective Biomarker Validation Plan for Clinical Qualification Introduction: Why a Biomarker Validation Plan Is Crucial Biomarkers are key instruments in translational medicine, enabling informed decision-making across drug development stages. Whether intended for diagnostic, prognostic, or monitoring use, biomarkers must be validated systematically before regulatory agencies will…

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Biomarkers and Companion Diagnostics, Validation Processes