制药业的校准转移和维护：系统回顾

IF 4.3 3区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutical Sciences Pub Date : 2025-04-25 DOI:10.1016/j.ejps.2025.107114

Ahmed Ramadan, Giverny Robert, Romain Kersaudy, Maroua Rouabah, Nicolas Abatzoglou, Ryan Gosselin

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引用次数: 0

摘要

有效的校准转移对于确保在改变光谱测量的一个或多个组件（包括光谱仪，样品特性，环境条件和测量设置）时准确可靠的测量是必不可少的。本文以一个独特的视角，旨在为制药研究人员提供指导，为校准转移和维护应用提供见解。系统评价列出了所有记录的校准转移和维护算法在制药行业的应用，直到手稿准备的时间。这些研究涵盖了各种类型的校准转移场景，包括内部供应商，供应商之间，不同的光谱技术，以及从台式仪器到小型化仪器的转移。校准维护案例揭示了变化的来源，如生产规模、温度变化、样品物理性质和过程的变化动态性质。该评论将算法与实践联系起来，同时突出了研究差距。这些差距包括在半固体或液体药品上的有限应用、有限的内联应用以及对最佳做法缺乏共识。通过解决这些缺点，本综述有助于推进制药行业的校准转移，支持精确测量，改进过程控制和开发高质量的药品。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Calibration transfer and maintenance in the pharmaceutical industry: a systematic review

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Calibration transfer and maintenance in the pharmaceutical industry: a systematic review

Effective calibration transfer is essential for ensuring accurate and reliable measurements on altering one or more components of spectroscopic measurements, including the spectrometers, sample characteristics, environmental conditions, and measurement settings. Taking a unique perspective, this review aims to provide a guide for pharmaceutical researchers, offering insights into calibration transfer and maintenance applications. The systematic review lists all documented applications of calibration transfer and maintenance algorithms in the pharmaceutical industry up until the time of manuscript preparation. These studies covered various types of calibration transfer scenarios, including intravendor, intervendor, different spectral technologies, and transfers from benchtop to miniaturized instruments. Calibration maintenance cases revealed sources of variation like production scale, temperature changes, sample physical properties, and varied dynamic nature of processes. The review links algorithms to practice while highlighting research gaps. These gaps include limited applications on semi-solid or liquid pharmaceutical products, limited inline applications, and a lack of consensus on best practices. By addressing these shortcomings, this review contributes to advancing calibration transfer in the pharmaceutical industry, supporting precise measurements, improved process control, and the development of high-quality pharmaceutical products.

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来源期刊

European Journal of Pharmaceutical Sciences 医学-药学

CiteScore

9.60

自引率

2.20%

发文量

248

审稿时长

50 days

期刊介绍： The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.