{"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}
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.
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.