原风险影响和缓解 (TRIM):为开发决策支持工具的研究协议,以优先考虑缓解风险的药物
Almut G Winterstein1,2,3, Celeste L Y Ewig4, Yanning Wang4,5
1Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA. almut@ufl.edu.
Drug safety
|November 5, 2024
概括
这项研究引入了原性风险影响和缓解 (TRIM) 工具,以优先考虑在怀孕期间构成风险的药物. TRIM评分将有助于监管机构决定哪些原药需要风险减轻策略.
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 生殖毒理学 生殖毒理学
背景情况:
- 预防产前接触产性药物对公共健康至关重要.
- 目前美国的11种原药的风险评估和缓解战略 (REMS) 计划可能不会针对最具影响力的药物.
- 缺乏REMS的原药物对公共卫生的影响还不清楚.
研究的目的:
- 开发一种创新的决策支持工具,以优先考虑原药物,以减轻风险.
- 该工具将使用明确的,可量化的标准,以基于证据的优先级.
- 促进有关毒性药物安全的知情监管决策.
主要方法:
- 一个国家小组将使用修改后的Delphi方法开发原风险影响和缓解 (TRIM) 工具.
- 多标准决策分析和离散选择实验将确定标准权重.
- 通过索赔数据识别的24种致病性药物 (12种有REMS,12种没有) 将计算TRIM分数,评估产前暴露流行率.
主要成果:
- 该TRIM工具提供了一个系统的框架,用于评估产物药物.
- 将使用可量化的标准和估计的权重来评估风险影响.
- 对于具有和没有现有REMS程序的药物,将生成TRIM分数.
结论:
- 该TRIM工具提供了明确的,可量化的,基于证据的标准,以告知监管决策对原药物风险减轻.
- 在REMS实施中,TRIM分数可以作为评估现有和新型原药物的基准.
- 这种方法旨在提高对毒性药物的监管风险减轻策略的有效性.
相关概念视频
01:21Factors Affecting Drug Response: Overview
1.9K
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
1.9K
01:28Preclinical Development: Overview
4.2K
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...
4.2K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
121
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,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
121
01:07Teratogenicity
2.4K
The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
2.4K
01:19Pharmacovigilance
776
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
776
01:25Drug Regulation
1.3K
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...
1.3K