期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 102, 期 9, 页码 2912-2923出版社
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.23570
关键词
regulatory science; PBPK; Modeling and simulation; systems pharmacology; pharmacodynamics; drug interactions; dose-response; pharamcokinetics
US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.
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