Jove
Visualize
お問い合わせ
JoVE
x logofacebook logolinkedin logoyoutube logo
JoVEについて
概要リーダーシップブログJoVEヘルプセンター
著者向け
出版プロセス編集委員会範囲と方針査読よくある質問投稿
図書館員向け
推薦の声購読アクセスリソース図書館諮問委員会よくある質問
研究
JoVE JournalMethods CollectionsJoVE Encyclopedia of Experimentsアーカイブ
教育
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab Manual教員リソースセンター教員サイト
利用規約
プライバシーポリシー
ポリシー

関連する概念動画

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

269
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...
269
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

こちらも読む

関連記事

共著者、ジャーナル、引用グラフによってこの研究に関連する記事。

並び替え
Same author

Advancing quantitative clinical pharmacology competencies in Francophone Africa through an on-line learning framework.

Journal of pharmacokinetics and pharmacodynamics·2026
Same author

Efficacy and safety of pyrimidine nucleos(t)ide therapy in thymidine kinase 2 deficiency.

Brain communications·2026
Same author

Two phase 1 randomised studies investigating the safety and pharmacokinetics of bepranemab in healthy participants of different ethnicities.

BMJ neurology open·2026
Same author

Safety, tolerability and biomarker results of bepranemab in participants with progressive supranuclear palsy: a randomised, multicentre, double-blind, placebo-controlled, phase 1b trial.

BMJ neurology open·2026
Same author

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients.

CPT: pharmacometrics & systems pharmacology·2026
Same author

Drug Development.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2025

関連する実験動画

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

薬物開発

Jagdev S Sidhu1, Maria Luisa Sardu2, Marcus A Björnsson3

  • 1UCB, Melbourne, VIC, Australia.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
まとめ
この要約は機械生成です。

ベプラネマブは、アルツハイマー病の進行を臨床マーカーを減少させることで遅らせる可能性を示しています。より高い用量は、前駆期から軽度のAD患者を対象とした将来の試験で、より大きな治療効果をもたらす可能性があります。

キーワード:
ベプラネマブアルツハイマー病タウタンパク質薬物開発モノクローナル抗体臨床試験

さらに関連する動画

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

446

関連する実験動画

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

446

科学分野:

  • 神経科学
  • 薬理学
  • 臨床試験

背景:

  • ベプラネマブは、アルツハイマー病（AD）の主要因子である凝集ヒトタウを標的とするモノクローナル抗体です。
  • TOGETHER試験では、前駆期から軽度のAD患者におけるベプラネマブの有効性と安全性を評価しました。

研究 の 目的:

  • ADにおけるベプラネマブ曝露と臨床転帰の関係をモデル化すること。
  • 将来の臨床開発における最適なベプラネマブ投与戦略を支持すること。

主な方法:

  • AD患者の部分集団からの薬物動態、人口統計、および有効性データの非線形混合効果モデリング。
  • CDR-SB、ADAS-Cog 14、およびタウPETの疾患進行モデルの開発。
  • 様々なベプラネマブ用量での80週間の治療転帰を予測するためのモデルベースシミュレーション。

主要な成果:

  • CDR-SB、ADAS-Cog 14、タウPETの進行は線形モデルで最もよく記述されました。
  • ベプラネマブ曝露は、すべての投与群でAD進行のマーカー減少と関連していました。
  • シミュレーションでは、45 mg/kgを超える用量はプラセボと比較して臨床転帰を改善する可能性があることが示唆されました。

結論:

  • 曝露-反応モデリングにより、タウ負荷が低い、またはAPOε4非キャリアの前駆期から軽度のAD患者におけるベプラネマブの臨床的有用性が確認されました。
  • より高いベプラネマブ用量は、将来の臨床試験でより治療的に有益であると予測されます。