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相关概念视频

Preclinical Development: Overview01:28

Preclinical Development: Overview

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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...
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Clinical Trials: Overview01:11

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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...
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Drug Discovery: Overview01:26

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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...
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Drug Administration and Therapy Phases: Overview01:26

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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...
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In Vitro Drug Release Testing: Overview, Development and Validation01:10

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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...
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Drug Regulation01:25

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

Jiong Shi1, Yun Xu2, Shenyu Zhao3

  • 1The First Affiliated Hospital of USTC, Hefei, anhui, China.

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PubMed
概括
此摘要是机器生成的。

针对β-粉样蛋白的抗体SHR-1707正在对阿尔茨海默病患者的长期疗效和安全性进行评估. 这一第二阶段试验将评估其在78周内对粉样蛋白沉积和认知功能的影响.

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科学领域:

  • 神经学 神经学
  • 免疫学 免疫学 免疫学
  • 药理学 药理学是指药理学的学科.

背景情况:

  • SHR-1707是一种人性化的IgG1单克隆抗体,向粉样β (Aβ),在阿尔茨海默病 (AD) 鼠标模型中已证明对Aβ物种的体外亲和力和体内疗效.
  • 第1阶段研究表明,SHR-1707在健康成年人和老年人中是安全的,耐受性良好.
  • 一个1b期试验显示,SHR-1707在患有轻度认知障碍 (MCI) 的患者中,由于AD或轻度AD,以剂量依赖的方式降低粉样蛋白,通常耐受性良好.

研究的目的:

  • 研究SHR-1707在患有因AD或轻度AD而导致MCI的患者的长期疗效和安全性.
  • 评估SHR-1707在78周内对大脑Aβ沉积的影响.
  • 评估SHR-1707在延长治疗期间的安全性和耐受性.

主要方法:

  • 一项随机,双盲,安慰剂控制的第2期研究 (NCT06199037) 涉及50-85岁的患有因AD或轻度AD而导致MCI的患者.
  • 参与者被随机分配 (2:1) 接受静脉注射SHR-1707 (10 mg/kg Q2W) 或安慰剂26周,根据ApoE ε4状态分层.
  • 一个开放的延期允许继续使用SHR-1707治疗52周,主要终点是通过PET成像在26周改变大脑Aβ沉积.

主要成果:

  • 该研究目前正在中国进行.
  • 主要业绩预计将在2025年第二季度出现.

结论:

  • 目前正在进行的第二阶段研究旨在提供关于SHR-1707.7的长期治疗潜力的关键数据.
  • 研究结果将阐明SHR-1707对阿米洛伊德病理和AD患者临床结果的持续影响.