临床前体外检测开发的设计质量。

IF 1.3 4区医学 Q4 PHARMACOLOGY & PHARMACY

Pharmaceutical Statistics Pub Date : 2024-09-24 DOI:10.1002/pst.2430

Jonathan Jones, Bairu Zhang, Xiang Zhang, Peter Konings, Pia Hansson, Anna Backmark, Alessia Serrano, Ulrike Künzel, Steven Novick

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引用次数: 0

摘要

质量源于设计（QbD）是一种化验开发方法，用于确定设计空间，也就是化验变量设置的范围，该范围应能带来令人满意的化验质量。QbD 通常应用于生产领域，但在临床前领域也同样有效。通过三个例子，我们说明了 QbD 方法与实验设计和相关数据分析的关系，以确定临床前检测的设计空间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Quality by Design for Preclinical In Vitro Assay Development.

Quality by Design (QbD) is an approach to assay development to determine the design space, which is the range of assay variable settings that should result in satisfactory assay quality. Typically, QbD is applied in manufacturing, but it works just as well in the preclinical space. Through three examples, we illustrate the QbD approach with experimental design and associated data analysis to determine the design space for preclinical assays.

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来源期刊

Pharmaceutical Statistics 医学-统计学与概率论

CiteScore

2.70

自引率

6.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Pharmaceutical Statistics is an industry-led initiative, tackling real problems in statistical applications. The Journal publishes papers that share experiences in the practical application of statistics within the pharmaceutical industry. It covers all aspects of pharmaceutical statistical applications from discovery, through pre-clinical development, clinical development, post-marketing surveillance, consumer health, production, epidemiology, and health economics. The Journal is both international and multidisciplinary. It includes high quality practical papers, case studies and review papers.