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関連する概念動画

Drug Discovery: Overview01:26

Drug Discovery: Overview

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...
Drug Regulation01:25

Drug Regulation

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

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Updated: Jun 6, 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

特許に基づく医薬品開発プロセス:根拠,問題,潜在的な改革

John H Barton1, Ezekiel J Emanuel

  • 1Department of Clinical Bioethics, National Institutes of Health, Bethesda, Md 20892-1156, USA.

JAMA
|October 27, 2005
PubMed
まとめ

薬の開発のための現在の特許制度は,アクセスを制限し,リソースを誤って割り当てています. 階層価格設定や公的資金の増加などの改革は,薬物アクセシビリティとイノベーションを向上させることができます.

科学分野:

  • 製薬業界 製薬産業 製薬産業は,医薬品を製造する業界です.
  • 健康経済学とは
  • 薬物開発政策 薬物開発政策

背景:

  • 製薬業界は,医薬品の価格設定,アクセス,研究優先事項に関する批判に直面しています.
  • 現在の特許に基づく医薬品開発システムの価値と公正性について根本的な疑問が存在します.
  • 問題には,アクセスするための財政的障壁,高い利益,そしてリソースの誤った配分が含まれます.

研究 の 目的:

  • 医薬品開発のための既存の特許制度を批判的に評価する.
  • 薬物アクセシビリティとイノベーションに影響を与える現在のシステム内の主要な問題を特定する.
  • より公平で効果的なシステムのために,潜在的な解決策と補完的な改革を提案する.

主な方法:

  • 製薬業界の特許制度とそれに関連する批判の分析.
  • 現在の特許に基づく医薬品開発モデルの6つの大きな問題点を特定する.
  • 価格設定,産業構造,開発インセンティブに潜在的な解決策を分類する.

主要な成果:

  • 特許制度は,薬物へのアクセスを妨げ,市場需要に対する研究優先順位を歪め,資源の誤った配分につながる可能性があります.
  • このシステムは,利益に比べて,研究開発への投資が全体的に不十分になる可能性があります.
キーワード:
分析的なアプローチ生物医学および行動研究保健医療と公衆衛生について

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Antibiotic Dereplication Using the Antibiotic Resistance Platform
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Antibiotic Dereplication Using the Antibiotic Resistance Platform

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Elucidation of the Material Basis of Yiqi Qingjie Formula Against IgA Nephropathy Using UHPLC-Q-Orbitrap HRMS Integrated with Network Pharmacology
08:44

Elucidation of the Material Basis of Yiqi Qingjie Formula Against IgA Nephropathy Using UHPLC-Q-Orbitrap HRMS Integrated with Network Pharmacology

Published on: May 19, 2026

関連する実験動画

Last Updated: Jun 6, 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

Antibiotic Dereplication Using the Antibiotic Resistance Platform
10:49

Antibiotic Dereplication Using the Antibiotic Resistance Platform

Published on: October 17, 2019

Elucidation of the Material Basis of Yiqi Qingjie Formula Against IgA Nephropathy Using UHPLC-Q-Orbitrap HRMS Integrated with Network Pharmacology
08:44

Elucidation of the Material Basis of Yiqi Qingjie Formula Against IgA Nephropathy Using UHPLC-Q-Orbitrap HRMS Integrated with Network Pharmacology

Published on: May 19, 2026

  • 既存の問題には,市場の失敗や特定の患者集団に対する差別が含まれます.

    • 結論:

    • 医薬品の価格設定,産業構造,開発インセンティブに対処するために改革が必要である.
    • 推奨される改革には,承認後の比較テスト,国際レベルの価格設定,政府資金の増額,バイアウトシステムなどがあります.
    • イノベーションが限られている状況では,標的型実験が推奨されます.