The Utility of Modeling and Simulation in Drug Development and Regulatory Review

Author:

Huang Shiew-Mei,Abernethy Darrell R.,Wang Yaning,Zhao Ping,Zineh Issam

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference58 articles.

1. US FDA innovative drug approvals. Accessed, at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm.

2. Regulatory science and the role of the regulator in biomedical innovation;Honig;Clin Pharmacol Ther,2012

3. US FDA Safety and Innovation Act (FDASIA). Accessed, at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

4. Medical product development and regulatory science for the 21st century: The critical path vision and its impact on health care;Buckman;Clin Pharmacol Ther,2007

5. The FDA critical path initiative and its influence on new drug development;Woodcock;Annu Rev Med,2008

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