对使用现实数据来测量骨质疏松症药物的暴露和使用模式的方法指南
Kaleen N Hayes1,2, Suzanne M Cadarette2,3,4,5, Andrea M Burden2,6
1Brown University School of Public Health, Providence, RI, USA.
来自观察性研究的真实世界证据 (RWE) 对于了解骨质疏松症药物至关重要. 使用真实世界数据 (RWD) 仔细测量药物暴露对于可靠的结果至关重要.
科学领域:
- 药理学和药理学流行病学
- 现实世界的证据 (RWE) 生产世代
- 骨质疏松症治疗研究研究
背景情况:
- 使用真实世界数据 (RWD) 的观察性研究补充了骨质疏松症药物的临床试验.
- 在RWD中的挑战包括多种药物类别,配方,施用途径和复杂的患者行为,如治疗间隔和切换.
- 特定的药物特性,如双酸盐和苏马布的延长半衰期,使暴露评估复杂化.
研究的目的:
- 提供关于准确测量RWD的骨质疏松症药物暴露的指导.
- 为了解决药物药理学和患者坚持模式所产生的复杂性.
- 提高对骨质疏松症治疗的RWE研究的可靠性和批判性评估.
主要方法:
- 对RWD来源的审查,以确定骨质疏松症药物使用.
- 对骨质疏松症药物药理学影响暴露测量决策的分析.
- 讨论测量暴露,坚持,切换,长期使用和药物假期的考虑因素.
主要成果:
- 不同的RWD来源需要不同的方法来识别药物使用.
- 了解药物药理学对于准确的RWD暴露评估至关重要.
- 为暴露测量的各个方面提供了方法指南.
结论:
- 在RWD中精确测量骨质疏松症药物暴露对于产生可靠的RWE至关重要.
- 对RWD来源和药物药理学的全面了解是必不可少的.
- 改进的测量实践将导致更有效的研究结果和更好的批判性评估.
更多相关视频
07:12Semiautomated Longitudinal Microcomputed Tomography-based Quantitative Structural Analysis of a Nude Rat Osteoporosis-related Vertebral Fracture Model
Published on: September 28, 2017
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
相关概念视频
Analysis of Population Pharmacokinetic Data
Osteoclasts in Bone Remodeling
Drug Concentrations: Measurements
Plasma...
Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Analysis Methods of Pharmacokinetic Data: Model and 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...
