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Updated: May 13, 2026

Detection of SARS-CoV-2 Neutralizing Antibodies using High-Throughput Fluorescent Imaging of Pseudovirus Infection
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与SARS-CoV-2中和单克隆抗体相关的不良事件使用FDA不良事件报告系统数据库

Min Joung Choi1, Se-Hun Oh2, Yun-Kyoung Song2

  • 1Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University, 309 Pilmun-Daero, Dong-gu, Gwangju, 61452 Republic of Korea.

Toxicological research
|September 30, 2024
PubMed
概括

这项研究使用美国FDA数据分析了抗严重急性呼吸系统综合征-冠状病毒-2 (SARS-CoV-2) 单克隆抗体的不良事件. 关键的安全信号包括缺氧,肺炎和过敏反应,需要仔细监测患者.

关键词:
不良事件是不良事件.在 COVID-19 疫情中,紧急使用授权.美国食品和药物管理局的不良事件报告系统.在SARS-CoV-2中和的单克隆抗体药物中.

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Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...