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相关概念视频

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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Drug Nomenclature01:17

Drug Nomenclature

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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
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Prodrugs01:30

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Prodrugs are a class of pharmaceutical compounds that undergo a biotransformation process within the body to be converted into a pharmacologically active drug. Prodrugs are designed to improve the therapeutic properties of the parent drug, such as enhancing bioavailability, increasing stability, or reducing toxicity. The concept of prodrugs revolves around modifying the chemical structure of the original drug to make it more effective or convenient for administration.
Prodrugs help overcome...
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Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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使用 Bayh-Dole Act 游行权来降低美国药物价格

Lisa Larrimore Ouellette1, Bhaven N Sampat2

  • 1Stanford Law School, Stanford, California.

JAMA health forum
|November 1, 2024
PubMed
概括
此摘要是机器生成的。

根据"贝伊-多尔法案" (Bayh-Dole Act) 的政府征集权,可以为有限数量的纳税人资助的药物提供仿制药的竞争. 然而,它们对增加通用药物获取的整体影响预计将是最小的.

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科学领域:

  • 卫生政策 卫生政策
  • 知识产权法 知识产权法 知识产权法
  • 制药经济学 制药经济学

背景情况:

  • 贝伊-多尔法案允许政府在联邦资助发明的专利上获得专利许可的"进军权".
  • 最近的提案建议将这些权利用于纳税人资助的药物,以促进仿制药竞争并降低成本.
  • 人们担心这种方法对制药创新的潜在影响以及这种方法的可行性.

研究的目的:

  • 评估政府游行权的潜力,以克服仿制药进入的专利障碍.
  • 在FDA色书中列出的药物中,量化符合征集权的专利的普遍性.

主要方法:

  • 一项横截面研究分析了FDA色书 (1985-2023) 中的专利政府资助数据.
  • 数据来源被结合起来,以识别来自联邦资助的专利,将其与室内研究专利区分开来.
  • 包括新的分子实体 (NME),所有持有色书专利的NDA,以及持有未过期专利的NDA.

主要成果:

  • 只有很小一部分药物拥有专利,这些专利完全来自联邦资金,受"贝伊-多尔法案"的约束.
  • 对于NME (1985-2022年),只有2%的人拥有贝伊-多尔专利.
  • 在所有拥有专利的药物 (1985-2023年) 中,只有1%的药物仅拥有贝伊-多尔专利.

结论:

  • 虽然Bayh-Dole的征集权理论上可以解决一些药物的专利障碍,但它们对仿制药竞争的实际影响是有限的.
  • 专门由联邦政府资助的专利的低普及率表明,在促进通用药物的获取方面,游行权的范围受到限制.