{"title":"Adequacy of safety data for regulatory approval of pediatric indication through extrapolation algorithm.","authors":"Min Soo Park","doi":"10.12793/tcp.2021.29.e11","DOIUrl":null,"url":null,"abstract":"https://tcpharm.org This commentary deals with the realistic difficulty arising from the haziness as to what safety data should mean, especially for regulatory authorities to feel confident that approval of new drug indications for pediatric populations could be endowed, and when you were guided that complete extrapolation of adult efficacy data would be possible with an additional pharmacokinetic (PK) study, but safety data cannot be extrapolated.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"29 2","pages":"73-77"},"PeriodicalIF":1.1000,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2e/4c/tcp-29-73.PMC8255546.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational and Clinical Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12793/tcp.2021.29.e11","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/6/21 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
https://tcpharm.org This commentary deals with the realistic difficulty arising from the haziness as to what safety data should mean, especially for regulatory authorities to feel confident that approval of new drug indications for pediatric populations could be endowed, and when you were guided that complete extrapolation of adult efficacy data would be possible with an additional pharmacokinetic (PK) study, but safety data cannot be extrapolated.
期刊介绍：
Translational and Clinical Pharmacology (Transl Clin Pharmacol, TCP) is the official journal of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT). TCP is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of translational and clinical pharmacology. The categories for publication include pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics, pharmacoepidemiology, pharmacovigilence, and human pharmacology. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.
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