儿科研究中的微采样:在全球儿科研究中对巴里西提尼布 (OlumiantTM) 的药理动力学采样
Enaksha R Wickremsinhe1, Rodney L Decker1, Lisa B Lee1
1Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN 46285, USA.
儿科药理动力学研究现在可以使用微量采样,通过Mitra®设备收集小体积的血液. 这种经过验证的方法简化了数据收集,并改善了儿科患者在临床试验中的招生.
科学领域:
- 药理动力学 药理动力学
- 临床药理学 临床药理学
- 儿科药物开发 儿科药物开发
背景情况:
- 在儿科研究中管理血液量是一个重大挑战.
- 尽量减少血液采集对于儿科患者的安全和舒适至关重要.
- 目前的方法对年轻参与者来说可能是侵入性的和繁重的.
研究的目的:
- 验证和实施用于儿科试验中的药理动力学数据收集的微样本采集技术.
- 评估小儿科患者群体中微量采样的可行性和接受性.
- 为了确定血和干血样本之间的一致性.
主要方法:
- 验证了一种敏感的液体色谱与双重质谱法 (LC-MS/MS) 方法.
- 在每个时间点使用Mitra®设备收集了10μl的血量.
- 在接受率>83%的情况下进行了所需样本再分析.
主要成果:
- 在两个全球III期儿科试验中成功实施了微量采样.
- 在老年儿科患者的血和干血样本之间建立了一致性.
- 在经过重新分析的样本中表现出高的接受率 (>83%).
结论:
- 微抽样是一种可行的和有效的方法,用于生成儿科患者 (年龄为2-18岁) 的药理动力学数据.
- 该技术得到了临床场所的好评,有助于儿科患者的入学.
- 微采样减少了在儿科临床研究中收集血液的负担.
更多相关视频
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
08:28Microsurgical Skills of Establishing Permanent Jugular Vein Cannulation in Rats for Serial Blood Sampling of Orally Administered Drug
Published on: December 14, 2021
相关概念视频
Pharmacokinetics: Overview
Noncompartmental Analysis: Miscellaneous Pharmacokinetic Parameters
One key aspect of the noncompartmental approach is determining a drug's total clearance. This can be done by dividing the drug dose by the area under the concentration-time curve from zero to infinity. The area under the concentration-time curve represents the drug's...
Analysis of Population Pharmacokinetic Data
Drug Concentrations: Measurements
Plasma...
Methods for Studying Drug Absorption: In vitro
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
Methods for Studying Drug Absorption: In situ
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
