Jove
Visualize
联系我们
JoVE
x logofacebook logolinkedin logoyoutube logo
关于 JoVE
概览领导团队博客JoVE 帮助中心
作者
出版流程编辑委员会范围与政策同行评审常见问题投稿
图书馆员
用户评价订阅访问资源图书馆顾问委员会常见问题
研究
JoVE JournalMethods CollectionsJoVE Encyclopedia of Experiments存档
教育
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab Manual教师资源中心教师网站
使用条款与条件
隐私政策
政策

相关概念视频

Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Drug Discovery: Overview01:26

Drug Discovery: Overview

10.9K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.9K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.1K
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

279
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
279
Drug Regulation01:25

Drug Regulation

2.7K
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...
2.7K

您也可能阅读

相关文章

通过共同作者、期刊和引用图与本文相关的文章。

排序
Same author

Emerging directions in tauopathy research.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same author

Nivolumab-Associated Cardiac Manifestation of Cutaneous T-Cell Lymphoma in a Patient With Concurrent Renal Cell Carcinoma.

Mayo Clinic proceedings. Innovations, quality & outcomes·2026
Same author

Reduction in Hepatic Phosphatidylcholine Biosynthesis Promotes MASH Through Copper Deficiency.

bioRxiv : the preprint server for biology·2026
Same author

Key Risks and Mitigation Strategies in AI-accelerated MRI.

Radiology·2026
Same author

A Phase 1 Oral Mass Balance and Combined Intravenous [<sup>14</sup>C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans.

Journal of clinical pharmacology·2026
Same author

Pharmacokinetic/pharmacodynamic analyses of plasma pathophysiology biomarkers in subjects with early Alzheimer's disease following lecanemab treatment.

Alzheimer's & dementia (New York, N. Y.)·2026
Same journal

Multimorbidity burden and patterns associated with DeepBrainNet-derived brain-age gap in dementia-free older adults: A community-based study.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Reply to "Shifting the emphasis of brain health literacy from individuals to systems to reduce inequalities".

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Shifting the emphasis of brain health literacy from individuals to systems to reduce inequalities.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Correlates and predictors of self-efficacy among dementia caregivers: D-CARE findings.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

What should convince a clinician of disease modification in Alzheimer's disease clinical trials?

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Primary cilia-extracellular vesicle crosstalk in Alzheimer's disease: Emerging mechanisms and biomarker potential.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
查看所有相关文章

相关实验视频

Updated: Jan 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

10.1K

药物开发 药物开发

Natasha Penner1, Sumit Rawal1, Jagadeesh Aluri1

  • 1Eisai Inc., Nutley, NJ, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
PubMed
概括
此摘要是机器生成的。

一种新的皮下lecanemab配方显示出有希望的结果,其疗效与静脉注射相当. 早期的研究证实了生物可用性,并探索生物等价性,以提高患者的便利性和安全性.

更多相关视频

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
08:04

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

Published on: May 11, 2021

3.3K
Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
05:45

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

451

相关实验视频

Last Updated: Jan 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

10.1K
In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
08:04

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

Published on: May 11, 2021

3.3K
Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
05:45

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

451

科学领域:

  • 药理学和药物开发领域
  • 临床试验和治疗方法
  • 神经科学和神经病学 神经科学和神经病学

背景情况:

  • 开发皮下lecanemab的目的是提高患者的便利性和安全性.
  • 早期的开发重点是确定皮下与静脉注射配方的生物可用性和生物等价性.

研究的目的:

  • 评估皮下lecanemab的生物可用性和药物动力学概况.
  • 为了确定lecanemab通过小瓶和自注射器给药的生物等价性.
  • 通过暴露-反应建模,预测皮下lecanemab配方的疗效.

主要方法:

  • 在健康成年人中进行了两项1期临床试验.
  • 研究1:随机评估皮下与静脉注射lecanemab的绝对生物可用性和药理动力学.
  • 研究2:皮下lecanemab小瓶和自身注射器之间的生物等价性的随机评估.

主要成果:

  • 皮下lecanemab显示了轻微的注射部位反应;静脉注射有输液相关的反应.
  • 皮下用莱卡内马布的绝对生物利用率为49.7%.
  • 虽然暴露-反应模型预测了所有配方的相似疗效,但在小瓶和自喷器之间没有证明生物等价性.

结论:

  • 皮下给药 (小瓶或自注射器) 实现了与静脉注射相比的平均稳定状态度.
  • 暴露-反应建模表明,类似的粉样蛋白斑降低和有效性跨管理路径.
  • 皮下lecanemab具有改善以患者为中心的管理的潜力.