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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

Mona Darwish1, Xiaoshu Feng1, Bryan Dirks1

  • 1Acadia Pharmaceuticals Inc., Princeton, NJ, USA.

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PubMed
概括
此摘要是机器生成的。

这项研究发现,ACP-204在健康的老年人和成年参与者中具有相似的药理动力学和安全性. 这种药物,ACP-204,正在针对阿尔茨海默病精神病 (ADP) 进行研究.

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科学领域:

  • 药理学 药理学是指药理学的学科.
  • 老年医学 老年医学
  • 神经科学是一个神经科学.

背景情况:

  • 阿尔茨海默病精神病 (ADP) 影响脆弱的老年患者易受抗精神病药物的副作用的影响.
  • 研究ACP-204,一个5-HT2A受体逆agonist/antagonist,用于ADP治疗.
  • 对老年人群来说,评估药物药理动力学 (PK) 和药理动力学中与年龄相关的差异至关重要.

研究的目的:

  • 在健康的老年人和成年参与者中评估ACP-204的药理动力学 (PK),安全性和耐受性.
  • 为了比较PK参数在60毫克的建议临床剂量.
  • 确定年龄是否影响ACP-204的药物暴露和安全概况.

主要方法:

  • 第1期,双盲,多重上升剂量研究在健康成年人和老年人.
  • 随机选择的参与者接受ACP-204口服剂量高达60毫克 (老年人) 和120毫克 (成年人).
  • 收集了稳定状态血样本进行PK分析 (Cmax-ss,AUCτ),重点是60毫克剂量.

主要成果:

  • 与60毫克的成年人相比,老年参与者显示Cmax-ss (1.14倍) 和AUCτ (1.20倍) 略高一些.
  • 平均半衰期 (t1/2) 相似:老年人19.8小时,成人17.8小时.
  • 在老年人和成年人群体中,安全性概况相似,没有意外发现.

结论:

  • 在健康的老年人和成年参与者中,ACP-204表现出质量相似的PK概况.
  • 暴露参数 (Cmax,ss和AUCτ) 显示出极小的差异 (在老年人中分别高14%和20%).
  • 在所有研究年龄组中,ACP-204通常是安全的,并且能很好地耐受.