以患者为中心的微抽样为支持Paxlovid临床开发:桥梁和实施
Katty Wan1, Olga Kavetska1, Bharat Damle1
1Pfizer Inc, New York, New York, USA.
Clinical pharmacology and therapeutics
|August 19, 2023
概括
使用Tasso-M20装置在家进行毛细血管血液采样是对尼尔马特里尔维尔 (PAXLOVID) 药理动力学研究的可行方法. 这种方法补充了传统的静脉采样,为COVID-19治疗研究提供了灵活性和便利.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
- 药物开发 药物开发
背景情况:
- 尼尔马特里尔维尔,与利托纳维尔一起作为PAXLOVID包装,是一种口服治疗COVID-19的治疗方法.
- 该药物获得了FDA的紧急使用授权和随后的批准,用于治疗SARS-CoV-2感染.
研究的目的:
- 评估使用Tasso-M20设备进行家庭毛细血管血液采样的实用性,用于对nirmatrelvir的药理动力学分析.
- 为了证明毛细血管血液样本和传统静脉血样本之间的一致性.
- 评估在全球临床试验中实施家庭采样的可行性和运营挑战.
主要方法:
- 使用Tasso-M20设备在家进行的毛细血管血样的药理动力学 (PK) 被整合到II/III期门诊和临床药理学研究中.
- 来自Tasso干血样本的度和PK参数与来自静脉血样本的度和PK参数进行了比较.
- 采用两部分人群的PK模型来弥合两种采样方法的数据.
主要成果:
- 在家Tasso采样成功补充了静脉采样,丰富了PK数据集并减少了患者的现场访问.
- 桥梁分析表明静脉血和Tasso干血结果之间的一致性/等效性.
- 运营挑战得到了有效的管理,收集了800多个样本,不到3%的样本被认为是无法使用的.
结论:
- 在家用Tasso-M20装置采集毛细血管血液样本是尼马特里尔维尔药理动力学研究的可靠和方便的方法.
- 这种方法提高了临床试验设计的灵活性,并支持在未来的研究中更广泛地实施.
- 获得的经验为优化全球药物开发计划中的家庭采样策略提供了宝贵的见解.
更多相关视频
05:31Noninvasive Sampling of Mucosal Lining Fluid for the Quantification of In Vivo Upper Airway Immune-mediator Levels
Published on: August 7, 2017
10.4K
08:37Sampling Human Indigenous Saliva Peptidome Using a Lollipop-Like Ultrafiltration Probe: Simplify and Enhance Peptide Detection for Clinical Mass Spectrometry
Published on: August 7, 2012
11.5K
相关概念视频
01:28Preclinical Development: Overview
4.5K
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...
4.5K
01:11Clinical Trials: Overview
3.0K
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...
3.0K
01:16Clinical Trials
6.8K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.8K