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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...
4.5K
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

Drug Administration and Therapy Phases: Overview

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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

Liqun Wang1, Joao Santos2, Amy England3

  • 1Harvard University, Boston, MA, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
まとめ

研究者らは、血液脳関門を克服し、脳への薬物送達を大幅に強化する新しい脳シャトルを開発した。これらの抗体シャトルは、治療薬の取り込みを改善し、特定の細胞を標的とすることにより、脳疾患の治療に有望であることを示している。

キーワード:
脳シャトル血液脳関門薬物送達神経疾患抗体工学

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科学分野:

  • 神経科学;バイオテクノロジー;薬理学

背景:

  • 血液脳関門（BBB）は、神経疾患の効果的な治療を妨げる、脳への治療薬送達にとって大きな課題となっている。脳内の特定の細胞や領域を標的とすることは、この生物学的障壁を克服する必要がある。

研究 の 目的:

  • BBBを介した薬物送達を強化するための新しい脳シャトルの開発と特性評価。治療薬を脳内の特定の細胞タイプおよび領域に標的化して送達できるようにする。

主な方法:

  • 脳微小血管内皮細胞上の受容体（TfR、CD98hc、ターゲット3）を標的とする脳シャトルパネルを開発した。ヒト化受容体ノックインマウスモデルにおけるシャトル薬物融合体を用いた細胞内輸送効率を評価した。免疫染色による脳薬物濃度を定量化し、細胞分布を視覚化した。

主要な成果:

  • リード抗TfRおよび抗CD98hcシャトルは、脳IgG取り込みを10倍以上に増加させた。抗TfRシャトルは迅速な脳内移行を提供し、抗CD98hcシャトルは最大4週間持続的な曝露を提供した。シャトルは、異なる細胞分布パターン（ニューロン対間質）を示した。

結論:

  • TfR、CD98hc、およびターゲット3を標的とする効率的な抗体脳シャトルを開発した。これらのシャトルは、様々なペイロードの脳取り込みと標的エンゲージメントを強化するように設計できる。開発されたシャトルは、脳疾患治療のための有望な戦略を表す。