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
{"title":"Mixture Experimentation in Pharmaceutical Formulations: A Tutorial.","authors":"Lynne B Hare, Stan Altan, Hans Coppenolle","doi":"10.1002/pst.2426","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":19934,"journal":{"name":"Pharmaceutical Statistics","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Statistics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pst.2426","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
求助全文
约1分钟内获得全文 去求助
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
Optimizing Sample Size Determinations for Phase 3 Clinical Trials in Type 2 Diabetes. Prediction Intervals for Overdispersed Poisson Data and Their Application in Medical and Pre-Clinical Quality Control. Treatment Effect Measures Under Nonproportional Hazards. Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment. PKBOIN-12: A Bayesian Optimal Interval Phase I/II Design Incorporating Pharmacokinetics Outcomes to Find the Optimal Biological Dose.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1