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相关概念视频

Pharmacokinetic Models: Overview01:20

Pharmacokinetic Models: Overview

627
Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
627
One-Compartment Open Model for IV Bolus Administration: General Considerations01:19

One-Compartment Open Model for IV Bolus Administration: General Considerations

175
The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
175
Drug Delivery: Parenteral Route01:29

Drug Delivery: Parenteral Route

450
The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
450
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

1.9K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
1.9K
One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution01:09

One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution

228
The one-compartment open model is a simplified approach used in pharmacokinetics to understand the distribution and elimination of a drug administered through an intravenous bolus. This model assumes rapid drug dispersal throughout the body and elimination using a first-order process. Key pharmacokinetic parameters, such as the elimination rate constant (k), half-life (t1/2), and the apparent volume of distribution (Vd), can be estimated from this model. The elimination rate is calculated...
228
Two-Compartment Open Model: IV Bolus Administration01:18

Two-Compartment Open Model: IV Bolus Administration

434
The two-compartment model for intravenous (IV) bolus administration illustrates drug distribution in the body, subdividing it into central and peripheral compartments. This model operates on the concept of two-compartment kinetics. The drug's plasma concentration shows a bi-exponential decline following IV bolus administration, signaling the presence of two disposition processes: distribution and elimination.
The disparity between drug input and the sum of drug transfer rates between...
434

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相关实验视频

Updated: Jun 16, 2025

The Quantification of Injectability by Mechanical Testing
04:46

The Quantification of Injectability by Mechanical Testing

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长效注射剂的杆模型主文件

Yuqing Gong1, Robert Hopefl1, Tonglei Li2

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.

Pharmaceutical research
|January 28, 2025
PubMed
概括

美国食品和药物管理局 (FDA) 和CRCG对监管机构提交的模型主文件 (MMF) 进行了探索. 货币货币基金有望改善药物开发的模式共享和效率,特别是长效注射剂.

关键词:
长效的注射剂可以使用.模型综合证据模型综合证据模型主文件模型主文件

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Slow-release Drug Delivery through Elvax 40W to the Rat Retina: Implications for the Treatment of Chronic Conditions
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Injectable Supramolecular Polymer-Nanoparticle Hydrogels for Cell and Drug Delivery Applications
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相关实验视频

Last Updated: Jun 16, 2025

The Quantification of Injectability by Mechanical Testing
04:46

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Published on: May 13, 2020

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Injectable Supramolecular Polymer-Nanoparticle Hydrogels for Cell and Drug Delivery Applications
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科学领域:

  • 监管科学 监管科学
  • 制药科学 制药科学
  • 计算建模 计算建模

背景情况:

  • 美国食品和药物管理局和CRCG召开了一场关于模型主文件 (MMF) 的研讨会.
  • 货币市场基金旨在在监管提交文件中标准化和共享模型整合证据 (MIE).
  • 专注于长效注射剂 (LAI) 和复杂的仿制药的应用.

研究的目的:

  • 总结关于货币市场基金的潜在监管应用的讨论.
  • 探索货币货币基金在LAI产品开发和监管提交中的实用性.
  • 确定货币货币基金实施的挑战和考虑因素.

主要方法:

  • 来自公开研讨会 (2024年5月2日至3日) 的总结演讲.
  • 包括来自小组和小组讨论的见解.
  • 审查的案例研究和潜在的货币市场基金在LAI开发中的应用.

主要成果:

  • 货币市场基金可以提高模式共享,标准化和监管效率.
  • 演讲涵盖了PBPK,多物理和popPK模型中的MMF应用.
  • 讨论了模型集成生物等价性 (MI-BE) 框架的潜在实用性.

结论:

  • 货币货币基金为模型开发者,行业和监管机构提供了重要的预期好处.
  • 对地方政府机构实施货币市场基金既有机遇又有挑战.
  • 货币市场基金准备简化复杂药品的监管流程.