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相关概念视频

Reliability and Validity01:29

Reliability and Validity

12.8K
Reliability and validity are two important considerations that must be made with any type of data collection. Reliability refers to the ability to consistently produce a given result. In the context of psychological research, this would mean that any instruments or tools used to collect data do so in consistent, reproducible ways.
12.8K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

148
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
148
Design Consideration01:22

Design Consideration

209
Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key...
209
Design Example: Analyzing Capacity Contours for Flood Risk Assessment01:17

Design Example: Analyzing Capacity Contours for Flood Risk Assessment

71
Flood risk assessment involves careful planning and analysis to ensure the safety of communities near water retention structures. Capacity contours are a vital tool in this process, as they illustrate the potential spread of water at specific levels in a given area. In the context of building a bund across a small valley, these contours play a critical role in evaluating the safety of nearby residential areas.In this example, the bund is intended to store stormwater in the valley. The engineers...
71
Relative Risk01:12

Relative Risk

219
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...
219
Factors Affecting Workability01:24

Factors Affecting Workability

91
The workability of concrete is a critical characteristic that influences the ease of mixing, handling, and finishing the concrete. It is affected by several factors including water content, aggregate properties, and admixtures like air entrainment. Water plays a fundamental role as it lubricates the concrete mix, facilitating easier movement and placement. However, the water requirement varies depending on the texture and shape of aggregates. Finer particles and angular, rough-textured...
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相关实验视频

Updated: Jul 19, 2025

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
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Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation

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基于风险的使用中的兼容性评估的实用工具.

Bruce D Mason1, Kris Lowe1, Jinquan Dong1

  • 1Drug Product and Device Development, Takeda Pharmaceuticals U.S.A., Inc. 200 Shire Way, Lexington, MA 02421, USA.

Journal of pharmaceutical sciences
|August 9, 2023
PubMed
概括

药物开发需要使用兼容性研究. 一个新的风险评估工具有助于确定是否需要对临床试验期间组件变化进行测试,从而可能节省大量的时间和资源.

科学领域:

  • 制药科学 制药科学
  • 药物开发 药物开发
  • 临床试验 临床试验

背景情况:

  • 使用中的兼容性研究对于药物产品在使用过程中的质量至关重要.
  • 临床试验期间药物输送组件的变化可能会导致延迟,需要进行广泛的评估.
  • 对于这些变化,缺乏基于科学的标准化风险评估方法.

研究的目的:

  • 开发一种风险评估工具,用于评估在临床试验期间药物输送组件发生变化时是否需要使用中的测试.
  • 在这种情况下,为决策提供标准化,基于科学的方法.
  • 加快药物开发时间表,减少不必要的测试.

主要方法:

  • 开发基于ExcelTM的半定量风险评估工具.
  • 基于多家公司在不同药物产品和地区进行兼容性研究的经验的工具.
  • 应用该工具来加快决策和减少在低风险情况下的测试.

主要成果:

  • 风险评估工具有助于确定在药物输送组件发生变化后是否需要使用时测试.
  • 该工具的实施可以加快决策和减少测试要求.
  • 在开发周期中,可以节省至少6-9个月的时间.
关键词:
运输 运输 运输 运输 运输 运输发展发展发展 发展发展酶 是一种酶.使用中的稳定性和兼容性.静脉内输入 静脉内输入单克隆抗体是一种单克隆抗体.风险评估 风险评估 风险评估基于科学的科学基础.工具 工具 工具 工具可能是MABS.

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结论:

  • 开发的风险评估工具为在临床试验期间管理组件变化提供了实际解决方案.
  • 它使得有效的,基于科学的评估,节省时间和资源.
  • 该工具可以适应各种药物产品,剂量方案,并且可以使资源有限的公司受益.