提交给美国食品和药物管理局的食品药物影响和儿科药物开发研究,2012-2022年
Kayla R Tunehag1, Blessy George2, Sherbet Samuels3
1Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Journal of clinical pharmacology
|January 31, 2024
概括
食品药物相互作用 (FDI) 没有在儿童中进行研究,尽管有生理上的差异. 这项研究确定了已知成人FDI的儿科药物,发现43%的儿童需要考虑食物,特别是两岁以下的婴儿.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科药物开发 儿科药物开发
- 药物新陈代谢 药物新陈代谢
背景情况:
- 食品效应 (FE) 研究评估食品药物相互作用,但未在儿童群体中进行.
- 与成年人相比,儿童患者表现出独特的生理学,解剖学和饮食特征,可能会改变药物反应.
- 了解儿童的FE对于安全有效的药物使用至关重要.
研究的目的:
- 为了确定已批准用于6岁以下儿童患者的口服药物产品,记录了成年FE.
- 总结这些药物的治疗领域,药理动力学效应和标签建议.
- 强调需要批准后监测,并探索儿科FE的预测工具.
主要方法:
- 搜索了FDA批准儿童使用 (2012-2022) 的口服药品的公开数据.
- 识别了具有现有的成人FE数据的产品,并分析了它们的标签说明.
- 研究的药理动力学参数 (AUCinf,Cmax) 受到食物的影响,特别是在较年轻的儿科组.
主要成果:
- 在批准用于6岁以下儿童的102种口服药物中,43% (42%) 在标签上考虑了FE.
- 推21种药物 (49%) 与食物一起使用,14种 (33%) 没有食物.
- 针对2岁以下儿童的药物显示出FE影响AUCinf (75%) 和Cmax (80%) 的比例最高.
结论:
- 对于已知成人FE的儿科药物,严密的批准后监测是必不可少的.
- 基于生理学上的药理动力学 (PBPK) 吸收建模显示,对预测儿科FE.有希望.
- 需要对儿科FE进行进一步的研究,以确保在这个脆弱人群中药物的安全性和有效性.
相关概念视频
Drug Regulation
1.4K
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...
1.4K
Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
Factors Affecting Drug Response: Overview
2.0K
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...
2.0K
Pharmacovigilance
833
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...
833
Preclinical Development: Overview
4.4K
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...
4.4K
Drug Administration and Therapy Phases: Overview
468
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...
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...
468


