药代动力学相似性研究中协方差分析与方差分析的比较。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2025-05-19 DOI:10.1002/jcph.70041

Brett A Martini, Ping Ji, Jiang Liu, Jan-Shiang Taur, Jianmeng Chen, Suresh Doddapaneni, Chandrahas Sahajwalla, Sarah J Schrieber

{"title":"药代动力学相似性研究中协方差分析与方差分析的比较。","authors":"Brett A Martini, Ping Ji, Jiang Liu, Jan-Shiang Taur, Jianmeng Chen, Suresh Doddapaneni, Chandrahas Sahajwalla, Sarah J Schrieber","doi":"10.1002/jcph.70041","DOIUrl":null,"url":null,"abstract":"The aim of this study was to evaluate the impact of demographic covariates on pharmacokinetic (PK) similarity assessment. A total of 30 PK similarity studies were analyzed to compare the use of analysis of covariance (ANCOVA) and analysis of variance (ANOVA). Trial simulations were conducted to further compare the two statistical approaches by varying sample size and covariates. Our analyses showed that ANCOVA and ANOVA were generally comparable in establishing PK similarity between the two products in the PK similarity studies. However, ANCOVA was observed to produce narrower confidence intervals and thus demonstrate higher power, particularly when the sample size was small.","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparison of Analysis of Covariance and Analysis of Variance in Pharmacokinetic Similarity Studies.\",\"authors\":\"Brett A Martini, Ping Ji, Jiang Liu, Jan-Shiang Taur, Jianmeng Chen, Suresh Doddapaneni, Chandrahas Sahajwalla, Sarah J Schrieber\",\"doi\":\"10.1002/jcph.70041\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The aim of this study was to evaluate the impact of demographic covariates on pharmacokinetic (PK) similarity assessment. A total of 30 PK similarity studies were analyzed to compare the use of analysis of covariance (ANCOVA) and analysis of variance (ANOVA). Trial simulations were conducted to further compare the two statistical approaches by varying sample size and covariates. Our analyses showed that ANCOVA and ANOVA were generally comparable in establishing PK similarity between the two products in the PK similarity studies. However, ANCOVA was observed to produce narrower confidence intervals and thus demonstrate higher power, particularly when the sample size was small.\",\"PeriodicalId\":48908,\"journal\":{\"name\":\"Journal of Clinical Pharmacology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-05-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/jcph.70041\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/jcph.70041","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

摘要

本研究的目的是评估人口统计学协变量对药代动力学（PK）相似性评估的影响。采用协方差分析（ANCOVA）和方差分析（ANOVA）对30个PK相似性研究进行分析比较。通过不同的样本量和协变量，进行试验模拟以进一步比较两种统计方法。我们的分析表明，在PK相似性研究中，ANCOVA和ANOVA在建立两种产品之间的PK相似性方面一般具有可比性。然而，观察到ANCOVA产生更窄的置信区间，因此显示出更高的功率，特别是当样本量较小时。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Comparison of Analysis of Covariance and Analysis of Variance in Pharmacokinetic Similarity Studies.

The aim of this study was to evaluate the impact of demographic covariates on pharmacokinetic (PK) similarity assessment. A total of 30 PK similarity studies were analyzed to compare the use of analysis of covariance (ANCOVA) and analysis of variance (ANOVA). Trial simulations were conducted to further compare the two statistical approaches by varying sample size and covariates. Our analyses showed that ANCOVA and ANOVA were generally comparable in establishing PK similarity between the two products in the PK similarity studies. However, ANCOVA was observed to produce narrower confidence intervals and thus demonstrate higher power, particularly when the sample size was small.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of Clinical Pharmacology PHARMACOLOGY & PHARMACY-

自引率

3.40%

发文量

期刊介绍： The Journal of Clinical Pharmacology (JCP) is a Human Pharmacology journal designed to provide physicians, pharmacists, research scientists, regulatory scientists, drug developers and academic colleagues a forum to present research in all aspects of Clinical Pharmacology. This includes original research in pharmacokinetics, pharmacogenetics/pharmacogenomics, pharmacometrics, physiologic based pharmacokinetic modeling, drug interactions, therapeutic drug monitoring, regulatory sciences (including unique methods of data analysis), special population studies, drug development, pharmacovigilance, womens’ health, pediatric pharmacology, and pharmacodynamics. Additionally, JCP publishes review articles, commentaries and educational manuscripts. The Journal also serves as an instrument to disseminate Public Policy statements from the American College of Clinical Pharmacology.