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相关概念视频

Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
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Assessing Body Temperature - Oral01:14

Assessing Body Temperature - Oral

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Here are the steps to accurately measure oral temperature using an electronic thermometer:
Step 1:
Start by practicing proper hand hygiene to prevent the spread of microorganisms.
Step 2:
Take the thermometer out of the charging unit, switch it on, and wait for the ready sign.
Step 3:
Gently slide the probe cover until a click is heard. This simple action prevents cross-contamination and ensures the correct placement of the probe cover.
Step 4:
Instruct the patient to open their mouth and place...
731
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

122
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...
122
Two-Compartment Open Model: IV Bolus Administration01:18

Two-Compartment Open Model: IV Bolus Administration

417
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...
417
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

222
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...
222
Drug Dosage Regimen: Overview01:15

Drug Dosage Regimen: Overview

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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
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相关实验视频

Updated: Jun 11, 2025

Formation of Dispersible Taohong Siwu Tablets
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温度外观管理:一种基于商业口服固体剂型的层级方法.

Shalini Raj Unnikandam Veettil1, Gianna Respicio1, DeeDee Zhang1

  • 1Gilead Sciences Inc., Foster City, California, 94404, USA.

The AAPS journal
|October 1, 2024
PubMed
概括

温度偏差可以影响药物的质量. 本研究提出了一种分层方法来评估温度外流对小分子药物的影响,确保产品的安全性和可用性.

关键词:
在Arrhenius方程中,货架寿命限制 时间限制固体口服剂量固体口服剂量稳定的稳定性 稳定的稳定性温度外流管理的温度外流管理.

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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科学领域:

  • 制药科学 制药科学
  • 供应链管理 供应链管理
  • 化学动力学 化学动力学

背景情况:

  • 储存,运输和处理期间的温度偏差可能会损害制药品质量.
  • 监管机构要求制药公司拥有强有力的程序来管理温度偏差和评估其影响.
  • 在复杂的制药供应链中,加快对温度外游事件的审查至关重要.

研究的目的:

  • 提出一种基于层级的方法来分析温度偏差对室温储存的小分子药物产品的影响.
  • 根据外出参数,建立温度外出后产品处置的标准.
  • 为了提供一个框架,有效和科学合理的温度外游事件的管理.

主要方法:

  • 一个基于外出温度和持续时间的三级影响评估系统.
  • 一级:在允许的温度和持续时间范围内,在没有进一步评估的情况下处置产品.
  • 2级:特定批量释放数据分析,如果温度在范围内,但持续时间超过范围.
  • 第三层:当外出温度超过允许限值时,用于影响评估的阿雷尼乌斯推断.

主要成果:

  • 1级允许对特定产品允许范围内的事件立即处置产品.
  • 2级使用现有的批量数据进行影响评估,当外出时间是限制因素时.
  • 第三层采用预测建模 (Arrhenius外推) 对于超过温度值的游览.

结论:

  • 提出的基于层次的方法为管理小分子药物产品的温度外观提供了一个结构化和有效的方法.
  • 这种方法促进了关于产品可用性的及时决策,平衡产品质量与供应链效率.
  • 该战略的实施有助于确保整个供应链的制药产品完整性.