异速缩放和索尔兹伯里规则在预测抗疟药物首次儿科剂量选择中的应用。

IF 1.9 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Iftekhar Mahmood
{"title":"异速缩放和索尔兹伯里规则在预测抗疟药物首次儿科剂量选择中的应用。","authors":"Iftekhar Mahmood","doi":"10.1007/s13318-023-00848-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In pediatric drug development, the selection of first-in-pediatric dose is of immense importance. Generally, the pharmacokinetic information and a safe and efficacious dose of a drug in adults are already known and this information can then be used to select first-in-pediatric dose. The objective of this study was to predict the pediatric dose of antimalarial drugs and compare the predicted dose with the recommended dose.</p><p><strong>Methods: </strong>In this study, two simple methods to project a first-in-pediatric dose to initiate a clinical trial for antimalarial drugs were evaluated. These two methods were Salisbury Rule and allometric scaling. The predicted doses of antimalarial drugs by the two methods were compared with the observed doses recommended by the World Health Organization (WHO) or the US Food and Drug Administration (FDA).</p><p><strong>Results: </strong>In this study, 15 antimalarial drugs with 88 observations (different body weight groups) were evaluated. From allometric scaling, all 88 observations were within 0.5-1.5-fold and 0.7-1.3-fold prediction error. From Salisbury Rule, all 88 observations were within 0.5-1.5-fold and 86 observations were within 0.7-1.3-fold prediction error.</p><p><strong>Conclusions: </strong>The proposed methods are simple and quite accurate in their predictive power. These methods can be developed on a spreadsheet or a calculator in a very short period of time and are applicable to first-in-pediatric clinical trials or even in a clinical setting.</p>","PeriodicalId":11939,"journal":{"name":"European Journal of Drug Metabolism and Pharmacokinetics","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of Allometric Scaling and Salisbury Rule for the Prediction of Antimalarial Drugs for First-in-Pediatric Dose Selection.\",\"authors\":\"Iftekhar Mahmood\",\"doi\":\"10.1007/s13318-023-00848-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In pediatric drug development, the selection of first-in-pediatric dose is of immense importance. Generally, the pharmacokinetic information and a safe and efficacious dose of a drug in adults are already known and this information can then be used to select first-in-pediatric dose. The objective of this study was to predict the pediatric dose of antimalarial drugs and compare the predicted dose with the recommended dose.</p><p><strong>Methods: </strong>In this study, two simple methods to project a first-in-pediatric dose to initiate a clinical trial for antimalarial drugs were evaluated. These two methods were Salisbury Rule and allometric scaling. The predicted doses of antimalarial drugs by the two methods were compared with the observed doses recommended by the World Health Organization (WHO) or the US Food and Drug Administration (FDA).</p><p><strong>Results: </strong>In this study, 15 antimalarial drugs with 88 observations (different body weight groups) were evaluated. From allometric scaling, all 88 observations were within 0.5-1.5-fold and 0.7-1.3-fold prediction error. From Salisbury Rule, all 88 observations were within 0.5-1.5-fold and 86 observations were within 0.7-1.3-fold prediction error.</p><p><strong>Conclusions: </strong>The proposed methods are simple and quite accurate in their predictive power. These methods can be developed on a spreadsheet or a calculator in a very short period of time and are applicable to first-in-pediatric clinical trials or even in a clinical setting.</p>\",\"PeriodicalId\":11939,\"journal\":{\"name\":\"European Journal of Drug Metabolism and Pharmacokinetics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Drug Metabolism and Pharmacokinetics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13318-023-00848-2\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Drug Metabolism and Pharmacokinetics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13318-023-00848-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

背景:在儿科药物开发中,儿科首用药剂量的选择是非常重要的。一般来说,药物在成人中的药代动力学信息和安全有效剂量是已知的,这些信息可以用来选择儿童首次用药剂量。本研究的目的是预测小儿抗疟药物的剂量,并将预测剂量与推荐剂量进行比较。方法:在本研究中,评估了两种简单的方法来预测首次在儿科剂量,以启动抗疟疾药物的临床试验。这两种方法分别是索尔兹伯里法则和异速标度法。将这两种方法预测的抗疟药物剂量与世界卫生组织(WHO)或美国食品和药物管理局(FDA)推荐的观察剂量进行比较。结果:本研究共对15种抗疟药物进行了88组(不同体重组)的评价。在异速尺度下,88个观测值的预测误差均在0.5-1.5倍和0.7-1.3倍之间。根据索尔兹伯里规则,88个观测值的预测误差均在0.5-1.5倍之间,86个观测值的预测误差在0.7-1.3倍之间。结论:方法简单,预测准确度高。这些方法可以在很短的时间内在电子表格或计算器上开发出来,并且适用于首次儿科临床试验,甚至在临床环境中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of Allometric Scaling and Salisbury Rule for the Prediction of Antimalarial Drugs for First-in-Pediatric Dose Selection.

Background: In pediatric drug development, the selection of first-in-pediatric dose is of immense importance. Generally, the pharmacokinetic information and a safe and efficacious dose of a drug in adults are already known and this information can then be used to select first-in-pediatric dose. The objective of this study was to predict the pediatric dose of antimalarial drugs and compare the predicted dose with the recommended dose.

Methods: In this study, two simple methods to project a first-in-pediatric dose to initiate a clinical trial for antimalarial drugs were evaluated. These two methods were Salisbury Rule and allometric scaling. The predicted doses of antimalarial drugs by the two methods were compared with the observed doses recommended by the World Health Organization (WHO) or the US Food and Drug Administration (FDA).

Results: In this study, 15 antimalarial drugs with 88 observations (different body weight groups) were evaluated. From allometric scaling, all 88 observations were within 0.5-1.5-fold and 0.7-1.3-fold prediction error. From Salisbury Rule, all 88 observations were within 0.5-1.5-fold and 86 observations were within 0.7-1.3-fold prediction error.

Conclusions: The proposed methods are simple and quite accurate in their predictive power. These methods can be developed on a spreadsheet or a calculator in a very short period of time and are applicable to first-in-pediatric clinical trials or even in a clinical setting.

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
CiteScore
3.70
自引率
0.00%
发文量
64
审稿时长
>12 weeks
期刊介绍: Hepatology International is a peer-reviewed journal featuring articles written by clinicians, clinical researchers and basic scientists is dedicated to research and patient care issues in hepatology. This journal focuses mainly on new and emerging diagnostic and treatment options, protocols and molecular and cellular basis of disease pathogenesis, new technologies, in liver and biliary sciences. Hepatology International publishes original research articles related to clinical care and basic research; review articles; consensus guidelines for diagnosis and treatment; invited editorials, and controversies in contemporary issues. The journal does not publish case reports.
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信