PKRxiv:通过开放的药理动力学数据共享来推进药理公平的最佳实践模型
Shakir Atoyebi1,2, Prajith Venkatasubramanian1,2, Abdulafeez Akinloye3,4
1Department of Biochemistry, Cell and Systems Biology, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
Clinical pharmacology and therapeutics
|February 1, 2026
概括
PKRxiv是一个新的存储库,使用FAIR原则促进药理动力学数据共享. 它通过使超过5500个数据点可访问,提高了药物开发的透明度和协作.
科学领域:
- 临床药理学 临床药理学
- 药物开发 药物开发
- 数据科学数据科学数据科学
背景情况:
- 基于模型的药物开发 (MIDD) 提高了试验效率,减少了动物试验.
- 药品公平需要公平地获得药品,数据和知识.
- 在共享药理动力学 (PK) 数据方面存在挑战.
研究的目的:
- 介绍PKRxiv,这是PK数据的学科特定存储库.
- 促进遵守可查找,可访问,可互操作,可重复使用 (FAIR) 原则.
- 促进透明和合作的临床药理学研究.
主要方法:
- 基于FAIR原则的PKRxiv存储库设计.
- 提交PK,药物遗传学和安全性/有效性数据的结构化数据.
- 灵活的数据共享模式 (不受限制,非商业,贡献者控制) 具有禁运选项.
主要成果:
- 在2025年9月之前,超过5,500个来自3大洲的900名参与者的个人药物度-时间数据点将在2025年9月之前提供.
- 持久的数字物体标识符 (DOI) 提供可发现性和引用性.
- 数据探索器和数据卡用于数据集探索.
结论:
- PKRxiv支持跨研究的数据聚合,以推进临床药理学.
- 建议包括获得对未来数据使用的同意和标准化数据共享.
- 鼓励行业在批准后共享数据,以促进透明度和公平.
相关概念视频
Model Approaches for Pharmacokinetic Data: Compartment Models
559
Compartmental analysis is a widely adopted approach to characterizing drug pharmacokinetics. It uses compartment models that conceptualize the body as a collection of reversibly communicating compartments, each representing a group of tissues exhibiting similar drug distribution characteristics. The movement rate of the drug between these compartments is typically described by first-order kinetics.
Two primary types of compartment models are recognized: mammillary and catenary. The more...
Two primary types of compartment models are recognized: mammillary and catenary. The more...
559
Model Approaches for Pharmacokinetic Data: Physiological Models
276
Physiological models in pharmacokinetics are instrumental in understanding the distribution and elimination of drugs within the body. These models describe the drug concentration within target organs, influenced by factors such as drug uptake, tissue volume, and blood flow. Drug uptake is governed by the partition coefficient, which signifies the drug concentration ratio in tissue to that in the blood. The blood flow rate to a specific tissue is expressed as Qt, and the rate of change in tissue...
276
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models
249
Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
249
Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches
539
Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...
539
Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis
330
Noncompartmental analyses offer an alternative method for describing drug pharmacokinetics without relying on a specific compartmental model. In this approach, the drug's pharmacokinetics are assumed to be linear, with the terminal phase log-linear. This assumption allows for simplified analysis and interpretation of the drug's behavior in the body.
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
330
Analysis of Population Pharmacokinetic Data
753
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
753


