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相关概念视频

Pharmacovigilance01:19

Pharmacovigilance

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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...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
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In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

593
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
593
Modified-Release Drug Delivery Systems: Overview01:19

Modified-Release Drug Delivery Systems: Overview

236
Modified-release dosage forms are designed to address the limitations of drugs with short biological half-lives. These forms maintain stable therapeutic drug concentrations over extended periods, reducing the need for frequent dosing. A consistent drug level helps minimize peak-trough fluctuations, which can reduce adverse effects, lower the risk of drug resistance, and improve overall treatment effectiveness.One common type of modified-release form is the extended-release (ER) formulation. ER...
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Modified-Release Drug Delivery Systems: Drug Release Characteristics01:22

Modified-Release Drug Delivery Systems: Drug Release Characteristics

257
Drug release from modified-release dosage forms is designed to achieve specific therapeutic effects by controlling the rate and extent of drug release. The classification of these drug release systems is based on key pharmacokinetic assumptions: drug disposition follows first-order kinetics, drug release is the rate-limiting step in absorption, and the released drug is rapidly and completely absorbed.There are four major models of drug release patterns. The first model is the slow zero-order...
257
Modified-Release Drug Delivery Systems: Classification01:23

Modified-Release Drug Delivery Systems: Classification

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Modified-release drug delivery systems improve drug efficacy and minimize side effects by controlling the rate and location of drug release. These systems fall into three categories: rate-programmed, stimuli-activated, and site-targeted.Rate-programmed systems release drugs at a predetermined rate, maintaining consistent therapeutic levels and reducing fluctuations that could lead to toxicity or subtherapeutic effects. These systems use polymeric matrices, reservoir-based designs, or osmotic...
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相关实验视频

Updated: May 1, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

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与非标签和未经测试的药物释放支架使用相关的结果和并发症.

Nirat Beohar1, Charles J Davidson, Kevin E Kip

  • 1Northwestern University Feinberg School of Medicine, Chicago, Ill, USA. n-beohar@northwestern.edu

JAMA
|May 10, 2007
PubMed
概括
此摘要是机器生成的。

非标签和未经测试的药物排泄支架 (DES) 的使用在穿皮冠状动脉干预 (PCI) 中很常见. 虽然非标签性DES使用的早期安全性较低,但非标签性和未经测试的指示的长期有效性降低,尽管绝对事件率仍然很低.

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Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
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科学领域:

  • 心血管医学 心血管医学
  • 干预心脏病学 干预心脏病学
  • 医疗器械技术 医疗器械技术

背景情况:

  • 有限的现实世界数据存在于药物释放支架 (DES) 在其批准的适用范围之外的使用.
  • 了解DES在非标签和未经测试的场景中的安全性和有效性对于临床实践至关重要.

研究的目的:

  • 评估DES在穿皮冠状动脉干预 (PCI) 期间用于非标签和未经测试的指示的频率,安全性和有效性.
  • 为了比较非标签和未经测试的DES使用与标准指示的结果.

主要方法:

  • 一个前性的多中心注册表评估了5541名在2005年1月至6月期间使用DES进行PCI的患者.
  • 根据病变特征,患者被分为标准,非标签或未经测试的使用组.
  • 评估的结果包括住院,30天和1年的综合死亡,心肌梗塞 (MI),支架血栓形成和目标血管再血管化.

主要成果:

  • 几乎一半 (47%) 的DES接受者接受了非标签或未经测试的适应症的支架.
  • 调整后的死亡,心脏病发作或支架血栓的住院风险在各组之间没有显著差异.
  • 在30天后,非标签使用显示复合终点的风险更高 (aHR,2.08),但这一差异在1年后减少.
  • 与标准使用相比,在非标签 (aHR,1.49) 和未经测试 (aHR,1.49) 的情况下,尽管绝对率较低,但目标血管再血管化率在一年内显著提高.

结论:

  • 在当代美国实践中,非标签和未经测试的DES使用普遍存在.
  • 虽然在非标签使用方面存在早期安全问题,但在非标签和未经测试的适用性方面,长期有效性降低了.
  • 绝对不良事件发生率仍然很低,这表明仔细选择患者和持续监测是关键.