对药物开发中当前QSP趋势的行业视角
1Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, Hertfordshire, UK. Lourdes.x.Cucurull-Sanchez@gsk.com.
Journal of pharmacokinetics and pharmacodynamics
|March 5, 2024
概括
定量和系统药理学 (QSP) 已成为一种重要的模型信息化药物开发 (MIDD) 工具,越来越多地用于监管提交. 这篇文章探讨了QSP.
科学领域:
- 药理学 药理学是指药理学的学科.
- 计算生物学 计算生物学
- 药物开发 药物开发
背景情况:
- 量化和系统药理 (QSP) 模拟支持了FDA的第一个监管决定.
- 在过去的五年里,QSP已经成熟成为一个有影响力的模型信息化药物开发 (MIDD) 工具.
- 向监管机构提交的QSP申请稳步增加,在2020年占IND申请的4%.
研究的目的:
- 检查QSP在制药行业取得成功的因素.
- 为了澄清QSP在MIDD范式中的作用.
- 在药物发现与临床开发中区分QSP应用.
主要方法:
- 审查QSP与监管流程的整合.
- 分析QSP模型类型 (平台与适合目的).
- 讨论QSP与药理动力学-药理动力学 (PKPD) 模型之间的协同作用.
主要成果:
- QSP已经从一个新兴的学科转变为药物开发的关键组成部分.
- 监管机构越来越多地接受QSP作为决策支持.
- 在发现和临床阶段,QSP模型在发现和临床阶段都有明显的优势.
结论:
- QSP的成功采用是由于其能够为关键药物开发决策提供信息的能力.
- 了解QSP的验证要求对于其有效使用至关重要.
- 质量标准是传统方法的补充工具,增强了MIDD框架.
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