Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2484813 | Journal of Pharmaceutical Sciences | 2013 | 12 Pages |
Abstract
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
Keywords
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Shiew-Mei Huang, Darrell R. Abernethy, Yaning Wang, Ping Zhao, Issam Zineh,