设计质量 设计实验设计的整合,用于平板电脑配方优化和过程验证
Jirapornchai Suksaeree1, Chaowalit Monton2,3, Pattwat Maneewattanapinyo4
1Department of Pharmaceutical Chemistry, College of Pharmacy, Rangsit University, Muang, 12000, Pathum Thani, Thailand. jirapornchai.s@rsu.ac.th.
AAPS PharmSciTech
|February 10, 2026
概括
设计质量 (QbD) 和实验设计 (DoE) 是制药开发的关键. 这次审查将DoE纳入口服药片开发的整个生命周期,从配方到验证,以系统地实现产品.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 药物开发 药物开发
背景情况:
- 设计质量 (QbD) 和实验设计 (DoE) 在制药开发中至关重要.
- 当前的方法往往分开制定,流程优化和验证.
- 为了有效开发平板电脑,需要一个统一的框架.
研究的目的:
- 为全面审查将DoE整合到口服药片开发的完整生命周期.
- 为了展示设计层面的 DoE 如何定义,完善和确认设计空间.
- 为科学家和制造团队提供一个实际的框架.
主要方法:
- 关于口服药片开发的已发表案例研究的叙事综述.
- 在制定到验证的路径上组织案例研究.
- 专注于将目标产品配置文件 (TPP) 转化为质量属性,并使用 DoE 进行配方和流程研究.
主要成果:
- 能源部的输出支持概率和机械设计空间定义.
- 能源部与扩展,技术转让和流程验证 (1-3阶段) 的整合.
- 在将DoE与过程分析技术 (PAT) 和数据驱动控制相结合时发现的挑战.
结论:
- 介绍了将DoE嵌入到基于QbD的平板电脑开发中的实用框架.
- 关键的缺口包括有限的基于概率的设计空间的使用和数字启用验证.
- 该审查综合了整个平板电脑开发生命周期的DoE应用程序.
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