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相关概念视频

Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Compartment Models: Single-Compartment Model01:14

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The single-compartment model serves as a simplified representation of the human body. This model assumes that the body functions as a single, well-mixed open compartment. When a drug is administered intravenously, it enters the body and quickly distributes uniformly. The drug then undergoes biotransformation and elimination, ultimately leaving the body. The volume of this compartment is referred to as the apparent volume of distribution into which the drug can uniformly distribute. In this...
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Scaled modeling is a fundamental technique in engineering, enabling the study of large and complex systems by creating smaller, manageable replicas that recreate critical characteristics of the original. In hydrology and civil infrastructure, for example, scaled models of dams help analyze water flow, turbulence, and pressure. This method allows for accurate predictions of real-world behavior within a controlled environment, significantly reducing the cost and time involved in full-scale...
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Data Validation01:15

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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Updated: Sep 9, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
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基于模拟的药物开发和制造内容统一工程

Kevin T Chu1, Remus Osan2, Nicole Tin2

  • 1Velexi Corporation, Burlingame, CA 94010, USA.

International journal of pharmaceutics
|September 3, 2025
PubMed
概括
此摘要是机器生成的。

随机模型和蒙特卡洛模拟评估内容统一性 (CU) 的风险. 这项研究为工艺化学家提供了设计颗粒大小分布 (PSD) 和管理制药制造中的CU风险的工具.

关键词:
内容一致性蒙特卡罗模拟颗粒大小分布

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科学领域:

  • 制药科学
  • 计算化学
  • 工艺工程

背景情况:

  • 随机模型和蒙特卡洛 (MC) 模拟对于评估制药制造中的含量统一性 (CU) 风险至关重要,减少了对广泛实验的需求.
  • 这些模拟的准确性和适当的应用对于它们在操作工作流程中的有用性至关重要.

研究的目的:

  • 分析基于活性药物成分 (API) 颗粒大小分布 (PSD) 的剂量方案的定量表征,提供早期CU风险指导.
  • 在MC模拟中验证上方颗粒尺寸切断直径的意义,考虑制造工艺和安全边缘.
  • 展示基于模拟的PSD工程和CU风险评估工具,整合到常见的药物开发工作流程中.

主要方法:

  • 对随机片形成模型的分析,以获得与APIPSD相关的定量剂量表征.
  • 蒙特卡洛 (MC) 模拟随机平板形成模型,以评估颗粒大小截止值的影响.
  • 为工艺化学家和配方人员开发基于模拟的工具,用于PSD工程和CU风险评估.

主要成果:

  • 根据API PSD开发了剂量方案的定量表征,提供了早期的CU风险指标.
  • 在MC模拟中选择适当的上颗粒尺寸切断直径的重要性得到了验证,并纳入制造工艺考虑和安全边缘.
  • 基于模拟的工具用于早期PSD目标指导,预测美国药典 (USP) < 905>的合格率,并确定低风险的APIPSD参数和剂量强度.

结论:

  • 随机建模和MC模拟为药物开发中评估和管理CU风险提供了强大的,经过验证的工具.
  • 基于模拟的方法可以进行积极的PSD工程和风险评估,优化药品制造过程.
  • 开发的工具为工艺化学家和配方人员提供了明智的决策,提高了药物开发的效率和可靠性.