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相关概念视频

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 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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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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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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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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Drug Classes and Categories01:25

Drug Classes and Categories

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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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相关实验视频

Updated: May 10, 2025

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
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Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

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支持仿制药质量的认证标志

Lars Lindgren1, Aaron S Kesselheim2, S Sean Tu3

  • 1University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States.

The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
|April 28, 2025
PubMed
概括
此摘要是机器生成的。

独立的认证标志可以通过验证超出FDA标准的质量来提高对仿制药的信任. 该系统提供了一种具有成本效益的方法来改善监督,特别是在全球供应链和FDA资源限制方面.

关键词:
美国食品药品监督管理局 FDA FDA仿制药是一般药物的.

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Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

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科学领域:

  • 制药政策 制药政策
  • 监管科学是一种监管科学.
  • 知识产权法 知识产权法

背景情况:

  • 在患者和处方者中,对仿制药质量的怀疑仍然存在.
  • 美国食品和药物管理局 (FDA) 的监督受资源限制和检查全球制造设施的挑战所限制.
  • 现有的监管框架可能无法完全解决消费者对仿制药的信任问题.

研究的目的:

  • 探索独立认证标志的潜力,以提高仿制药质量的认知和监督.
  • 提出一个补充系统,以增强对仿制药的信任,而无需修改立法.
  • 确定认证标志如何激励制造商超越基准质量标准.

主要方法:

  • 认证标志系统 (例如,美国农业部有机,能源之星) 的概念分析及其对药品的适用性.
  • 对仿制药的独立质量验证的潜在好处的评估.
  • 评估与现行FDA法规一起实施这种系统的可行性.

主要成果:

  • 认证标志可以作为一种有价值的工具,向消费者传达药品质量.
  • 独立验证可以激励制造商实现更高的质量标准.
  • 一个认证系统可以补充FDA的检查,特别是在全球化市场.

结论:

  • 独立的认证标志提供了一个有希望的,具有成本效益的机制,以改善仿制药质量认知和监督.
  • 这种方法可以增强消费者和处方者对仿制药的信心.
  • 认证标志是加强对制药供应链的信任的可行策略.