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相关概念视频

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges09:33

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges

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Here we present a protocol outlining how to sample wooden specimens for the overall assessment of their growth structures. Macro- and microscopic preparation and visualization techniques necessary to generate well-replicated and highly resolved wood anatomical and dendroecological dataset, are described are...
29.6K
Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices08:01

Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices

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Co-cultures represent a valuable method to study the interactions between nerves and target tissues and organs. Microfluidic systems allow co-culturing ganglia and whole developing organs or tissues in different culture media, thus representing a valuable tool for the in vitro study of the crosstalk between neurons and their...
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Development of a 3D Graphene Electrode Dielectrophoretic Device11:15

Development of a 3D Graphene Electrode Dielectrophoretic Device

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A microdevice with high throughput potential is used to demonstrate three-dimensional (3D) dielectrophoresis (DEP) with novel materials. Graphene nanoplatelet paper and double sided tape were alternately stacked; a 700 μm micro-well was drilled transverse to the layers. DEP behavior of polystyrene beads was demonstrated in the...
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In Vitro Thrombosis Test for Ventricular Assist Devices09:15

In Vitro Thrombosis Test for Ventricular Assist Devices

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We present a benchtop protocol to induce thrombosis in ventricular assist devices (VAD) within a recirculating test platform. This method serves to identify thrombogenic hotspots in the blood flow path and can help improve thromboresistance ahead of preclinical testing in animal...
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Continuous Venous-Arterial Doppler Ultrasound During a Preload Challenge09:32

Continuous Venous-Arterial Doppler Ultrasound During a Preload Challenge

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The Frank-Starling-Sarnoff curve is clinically important and describes the relationship between cardiac preload and output. This report illustrates a novel method of simultaneous jugular venous and carotid arterial Doppler velocimetry as transient surrogates of cardiac preload and output, respectively; this approach is enabled by wireless, wearable Doppler...
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Relative Risk01:12

Relative Risk

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Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
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相关实验视频

Updated: Jan 20, 2026

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges
09:33

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges

Published on: March 5, 2015

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克服预装注射器开发中的设备组件相关的挑战和风险.

Bettine Boltres1, Fran deGrazio2, Susan Neadle3

  • 1West Pharmaceutical Services bettine.boltres@westpharma.com.

PDA journal of pharmaceutical science and technology
|January 18, 2026
PubMed
概括

开发预填注射器 (PFS) 涉及复杂的监管和技术挑战. 本文确定了四个系统性问题,并提出了为安全有效的PFS提供更高效和可预测的开发过程的策略.

科学领域:

  • 制药发展 制药发展
  • 组合产品法规 组合产品法规
  • 医疗器械工程 医疗器械工程

背景情况:

  • 预填注射器 (PFS) 是一种具有复杂发展途径的组合产品.
  • 在PFS开发中的挑战可能会导致延迟,成本增加和市场准入障碍.
  • 现有的问题往往源于系统性的,而不是孤立的技术故障.

研究的目的:

  • 识别和分析预填注射器开发中的系统性挑战.
  • 为了说明这些挑战如何在开发过程中表现为具体的风险.
  • 提出系统层面的策略,以减轻风险和改善PFS的发展.

主要方法:

  • 分析PFS开发中的反复出现的问题.
  • 检查特定的例子,如破解力,油,颗粒,内毒素和生物相容性.
  • 审查监管互动,包括医疗器械条例 (MDR) 规定的互动.

主要成果:

  • 确定了四个主要的系统性挑战:分歧的监管要求,分化的能力,分散的供应链和非标准化的表征.
  • 这些挑战在过渡 (例如,瓶子到注射器) 和监管合规性方面会产生风险.
  • 具体的例子强调了这些挑战对产品开发的影响.
关键词:
产品组合是产品组合.设备组件的组成部分.设备开发 设备开发预先填充的注射器主要包装组件的主要包装组件.

更多相关视频

Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices
08:01

Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices

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Development of a 3D Graphene Electrode Dielectrophoretic Device
11:15

Development of a 3D Graphene Electrode Dielectrophoretic Device

Published on: June 22, 2014

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相关实验视频

Last Updated: Jan 20, 2026

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges
09:33

A Technical Perspective in Modern Tree-ring Research - How to Overcome Dendroecological and Wood Anatomical Challenges

Published on: March 5, 2015

29.6K
Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices
08:01

Analysis of Developing Tooth Germ Innervation Using Microfluidic Co-culture Devices

Published on: August 14, 2015

8.6K
Development of a 3D Graphene Electrode Dielectrophoretic Device
11:15

Development of a 3D Graphene Electrode Dielectrophoretic Device

Published on: June 22, 2014

12.5K

结论:

  • 应对系统性挑战需要综合风险管理,更清晰的系统所有权和早期合作.
  • 协调标准和监管期望对于高效的发展至关重要.
  • 实施这些策略支持可预测的,基于科学的安全和有效的PFS途径.