Mixture Experimentation in Pharmaceutical Formulations: A Tutorial.

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pharmaceutical Statistics Pub Date : 2024-08-05 DOI:10.1002/pst.2426
Lynne B Hare, Stan Altan, Hans Coppenolle
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Abstract

Mixture experimentation is commonly seen in pharmaceutical formulation studies, where the relative proportions of the individual components are modeled for effects on product attributes. The requirement that the sum of the component proportions equals 1 has given rise to the class of designs, known as mixture designs. The first mixture designs were published by Quenouille in 1953 but it took nearly 40 years for the earliest mixture design applications to be published in the pharmaceutical sciences literature by Kettaneh-Wold in 1991 and Waaler in 1992. Since then, the advent of efficient computer algorithms to generate designs has made this class of designs easily accessible to pharmaceutical statisticians, although the use of these designs appears to be an underutilized experimental strategy even today. One goal of this tutorial is to draw the attention of experimental statisticians to this class of designs and their advantages in pursuing formulation studies such as excipient compatibility studies. We present sufficient materials to introduce the novice practitioner to this class of design, associated models, and analysis strategies. An example of a mixture-process variable design is given as a case study.

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药物制剂中的混合物实验:教程。
混合物实验常见于药物制剂研究中,通过模拟单个成分的相对比例来确定对产品属性的影响。各组分比例之和等于 1 的要求产生了一类设计,即混合物设计。最早的混合设计由 Quenouille 于 1953 年发表,但过了近 40 年,Kettaneh-Wold 和 Waaler 才分别于 1991 年和 1992 年在制药科学文献中发表了最早的混合设计应用。从那时起,生成设计的高效计算机算法的出现使这一类设计很容易为制药统计学家所使用,尽管时至今日,使用这些设计似乎仍是一种未得到充分利用的实验策略。本教程的目的之一是提请实验统计人员注意这类设计及其在辅料相容性研究等制剂研究中的优势。我们将提供足够的材料,向新手介绍这类设计、相关模型和分析策略。我们还给出了一个混合过程变量设计的案例。
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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来源期刊
Pharmaceutical Statistics
Pharmaceutical Statistics 医学-统计学与概率论
CiteScore
2.70
自引率
6.70%
发文量
90
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.
期刊最新文献
Beyond the Fragility Index. A Model-Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology. Potential Bias Models With Bayesian Shrinkage Priors for Dynamic Borrowing of Multiple Historical Control Data. Subgroup Identification Based on Quantitative Objectives. A Bayesian Dynamic Model-Based Adaptive Design for Oncology Dose Optimization in Phase I/II Clinical Trials.
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