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

Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

6.1K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
6.1K
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
Clinical Trials01:16

Clinical Trials

10.1K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.1K
Quality Assurance01:19

Quality Assurance

926
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
926
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

178
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
178
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

376
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
376

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

Towards Pharma 4.0 in clinical trials: A future-orientated perspective.

Drug discovery today·2021
Same author

A blockchain technology based trust system for cloud manufacturing.

Journal of intelligent manufacturing·2021
Same author

Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0.

International journal of pharmaceutics·2019
Same author

Natural products and the aging process.

Hormone molecular biology and clinical investigation·2014
Same author

Evaluation of an Aqueous-Ethanolic Extract from Rosmarinus officinalis (Rosemary) for its Activity on the Hormonal and Cellular Function of Testes in Adult Male Rat.

Iranian journal of pharmaceutical research : IJPR·2013
Same author

Carbonyl stress in aging process: role of vitamins and phytochemicals as redox regulators.

Aging and disease·2013

関連する実験動画

Updated: Jan 8, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.1K

臨床試験のためのブロックチェーン活用品質設計（QbD）システム

Reza Vatankhah Barenji1, Reza Ebrahimi Hariry2

  • 1Department of Engineering, School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom.

Frontiers in medicine
|December 22, 2025
PubMed
まとめ

ブロックチェーン技術は、データ整合性と参加者の安全性を向上させることにより、臨床試験の品質設計（QbD）を強化します。この安全で分散化されたアプローチは、データの一貫性を高め、プロセスの検証を強化し、より良い試験管理を実現します。

科学分野:

  • 臨床研究;データ管理;情報技術

背景:

  • 品質設計（QbD）は臨床試験の整合性にとって極めて重要です。;現在の試験におけるデータ管理は、整合性と透明性に課題を抱えています。;ブロックチェーン技術は、安全で分散化されたデータ処理のための新しいソリューションを提供します。

研究 の 目的:

  • 臨床試験のためのブロックチェーン活用品質設計（QbD）アーキテクチャを開発・評価すること。;臨床試験プロセスにおけるデータ整合性、参加者の安全性、トレーサビリティを向上させること。;臨床データ管理におけるブロックチェーン統合の実現可能性とスケーラビリティを実証すること。

主な方法:

  • ブロックチェーン活用QbDアーキテクチャを開発しました。;Hyperledger Fabricを使用してプロトタイプを実装しました。;パイロット臨床試験データを使用してシステムの適用性を評価しました。

主要な成果:

  • アーキテクチャは、不変のデータ交換とQbD活動のトレーサビリティ向上を促進しました。;ステークホルダー間の安全なコラボレーションがサポートされました。;データの一貫性が向上し、試験プロセスの自動検証が可能になりました。

結論:

  • ブロックチェーン技術は、臨床試験におけるQbDの実装を効果的に強化します。;提案されたアーキテクチャは、データ統合、透明性、安全性モニタリングを改善します。;このモデルは、将来の臨床データ管理システムのための実現可能でスケーラブルなソリューションを提供します。
キーワード:
PDCAブロックチェーン技術臨床試験創薬品質設計

さらに関連する動画

In Silico Clinical Trials for Cardiovascular Disease
09:09

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

2.2K
Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
13:24

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

Published on: April 11, 2016

12.2K

関連する実験動画

Last Updated: Jan 8, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.1K
In Silico Clinical Trials for Cardiovascular Disease
09:09

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

2.2K
Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
13:24

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

Published on: April 11, 2016

12.2K