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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...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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

Drug Discovery: Overview

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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

In Vitro Drug Release Testing: Overview, Development and Validation

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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

Drug Regulation

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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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薬物開発

John E Harrison1

  • 1Alzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Amsterdam, Amsterdam, Netherlands; King's College - Institute of Psychiatry, Psychology & Neuroscience, London, London, United Kingdom; Metis Cognition Ltd., Kilmington, Wiltshire, United Kingdom.

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PubMed
まとめ
この要約は機械生成です。

批判にもかかわらず、アルツハイマー病評価尺度-認知(ADAS-cog)は認知症研究の標準であり続けている。新しい認知評価は、アルツハイマー病(AD)の早期発見と進行追跡に有望である。

キーワード:
アルツハイマー病認知症ADAS-cog認知評価薬物開発

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

  • 神経科学;臨床心理学;老年医学

背景:

  • アルツハイマー病評価尺度-認知(ADAS-cog)は、アルツハイマー病(AD)研究における主要な認知評価でした。広範な使用にもかかわらず、ADAS-cogは天井効果や内容妥当性の低さなど、重大な批判に直面しています。2000年以降、多数の代替認知評価が開発され、より優れた領域カバレッジとアッセイ感度を提供しています。

研究 の 目的:

  • アルツハイマー病研究における認知評価の歴史的発展と継続的な使用をレビューすること。ADAS-cogの限界と、より優れた代替案の出現を強調すること。AD研究を進歩させるための、より効果的な認知ツールの採用を提唱すること。

主な方法:

  • 2000年から現在までのアルツハイマー病(AD)研究で使用されている認知評価ツールのレビュー。新しい評価と比較したADAS-cogの長所と短所の分析。早期AD段階のための複合認知スコアの開発と適用の検討。

主要な成果:

  • 欠点はあるものの、ADAS-cogはAD創薬における好ましい認知評価であり続けています。新しい認知バッテリーおよび複合スコア(例:PACC、ADCOMS)は、特に早期AD段階において、より優れたアッセイ感度を示します。ADAS-cogの欠点を克服するためのかなりの研究努力がなされており、評価戦略の更新が必要であることが示唆されています。

結論:

  • ADAS-cogの限界は、AD研究においてより感度が高く、妥当性の高い認知評価への移行を必要とします。最適化された複合スコアは、早期ADの検出とモニタリングの改善の可能性を示しています。現在および今後の認知ツールのより効果的な利用は、アルツハイマー病の研究と治療の進歩を加速することができます。