کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2484813 | 1114338 | 2013 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The Utility of Modeling and Simulation in Drug Development and Regulatory Review
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: The Utility of Modeling and Simulation in Drug Development and Regulatory Review The Utility of Modeling and Simulation in Drug Development and Regulatory Review](/preview/png/2484813.png)
چکیده انگلیسی
ABSTRACT: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. 102:2912–2923, 2013
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 102, Issue 9, September 2013, Pages 2912–2923
Journal: Journal of Pharmaceutical Sciences - Volume 102, Issue 9, September 2013, Pages 2912–2923
نویسندگان
Shiew-Mei Huang, Darrell R. Abernethy, Yaning Wang, Ping Zhao, Issam Zineh,