Art

J-GLOBAL ID：201902243130966662   Reference number：19A1578434

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

機械学習方法論に基づく新しい化学物質のための最初の略breviされた新しい薬物応用サブミッションの予測分析【JST・京大機械翻訳】

Author (10)： Hu Meng (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Babiskin Andrew (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Wittayanukorn Saranrat (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Schick Andreas (Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Rosenberg Matthew (Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Gong Xiajing (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Kim Myong-Jin (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Zhang Lei (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Lionberger Robert (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA) ,  Zhao Liang (Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA)
Material： Clinical Pharmacology & Therapeutics  (Clin Pharmacol Ther)
Volume： 106  Issue： 1  Page： 174-181  Publication year： 2019 
JST Material Number： A0721B  ISSN： 0009-9236  Document type： Article
Article type： 原著論文  Country of issue： United States (USA)  Language： ENGLISH (EN)

Abstract/Point： Generic drug products are appr...

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Thesaurus term： resource allocation ,  *chemical substance ,  modeling ,  Food and Drug Administration ,  *Machine Learning ,  *forecast ,  regression model ,  product information
Semi thesaurus term： 予測性能 ,  外部検証 , 【Automatic Indexing@JST】

JST classification (1)： Clinical biopharmacy  (GY01022L)

Terms in the title (9)： 機械学習 ,  方法論 ,  化学物質 ,  薬物 ,  応用 ,  サブ ,  ミッション ,  予測 ,  分析