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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

3.0K
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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Preclinical Development: Overview01:28

Preclinical Development: Overview

4.8K
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...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

300
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...
300
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

343
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,...
343
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

97
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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相关实验视频

Updated: May 5, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
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In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver

Published on: May 4, 2016

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美国FDA/CDER/OND对新方法方法 (NAMs) 的经验.

Jia Yao1, Jackye Peretz1, Ilona Bebenek1

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

International journal of toxicology
|November 13, 2025
PubMed
概括
此摘要是机器生成的。

美国食品和药物管理局 (FDA) 鼓励新方法方法 (NAMs) 用于药物安全测试. 这个视角详细介绍了NAM的历史整合,审查员的见解和未来的方向,以推进监管科学和保护公共健康.

关键词:
美国食品和药物管理局/CDER/OND.在体内非人体试验.创新的药物开发创新的药物开发.新方法方法论 (NAMs)非临床试验的试验.药理学/毒理学 药理学/毒理学

相关实验视频

Last Updated: May 5, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
10:38

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver

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科学领域:

  • 监管科学 监管科学
  • 毒理学 毒理学 毒理学
  • 药物开发 药物开发

背景情况:

  • 美国食品和药物管理局的药物评估和研究中心 (CDER) 积极促进在非临床测试中使用新方法方法 (NAMs).
  • 以前的FDA / CDER出版物已经解决了药物开发当前非临床测试方法的战略,挑战和差距.
  • 通过采用NAMs,不断努力改进,减少和取代动物试验.

研究的目的:

  • 为了证明NAMs在FDA/CDER标准非临床评估中的历史纳入.
  • 提供CDER/新药局 (OND) 药理学/毒理学审查员对评估NAM提交的新药开发的见解.
  • 概述未来将NAM整合到非临床药物开发计划中,以反映不断发展的科学技术.

主要方法:

  • 对FDA/CDER关于验证和接受NAM作为动物试验替代品的历史实践的审查.
  • 汇编了CDER/OND药理学/毒理学审查人员对提交的NAM数据进行监管决策的观点.
  • 对当前趋势的分析以及将NAM纳入非临床药物安全评估的未来考虑.

主要成果:

  • 特定的NAM已经成功验证并被接受为国际公认的动物试验替代品,用于监管目的.
  • 美国食品和药物管理局/CDER在评估NAM提交时采用了结构化的科学方法,确保科学严谨性和监管合规性.
  • 审查员的经验凸显了NAM在支持新药的安全性和有效性方面的实用性和挑战.

结论:

  • 美国食品和药物管理局/CDER/OND致力于通过战略性纳入NAM来实现动物试验中的3R (替代,减少,改进).
  • 分享经验和提供关于NAM提交的指导旨在促进对监管评估流程的信心.
  • 持续鼓励NAM提交支持FDA保护公共健康的使命,同时推进创新药物开发.