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Model‐Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop
Author(s) -
Fang Lanyan,
Kim MyongJin,
Li Zhichuan,
Wang Yaning,
DiLiberti Charles E.,
Au Jessie,
Hooker Andrew,
Ducharme Murray P.,
Lionberger Robert,
Zhao Liang
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1065
Subject(s) - session (web analytics) , drug development , food and drug administration , drug , medicine , computer science , pharmacology , management science , engineering , world wide web
On October 2 nd and 3 rd , 2017, the US Food and Drug Administration (FDA) hosted a public workshop titled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” 1 This report summarizes Session 2 of the public workshop: “Model Informed Drug Development and Review for Generic Products.” The session focused on the application of quantitative methods and modeling in modernizing the generic drug development and review.