New Drug Development Paradigms in China: Simultaneous Global Drug Development Program

2016 ◽  
pp. 281-294
Keyword(s):  
Drug Development ◽  
Development Program ◽  
New Drug ◽  
New Drug Development ◽  
Drug Development Program ◽  
Global Drug Development

Design and Sample Size Considerations for Simultaneous Global Drug Development Program

2012 ◽  
Vol 22 (5) ◽  
pp. 1060-1073 ◽  
Author(s):  
Qin Huang ◽  
Gang Chen ◽  
Zhilong Yuan ◽  
K. K. Gordon Lan
Keyword(s):  
Drug Development ◽  
Sample Size ◽  
Development Program ◽  
Drug Development Program ◽  
Global Drug Development

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

A nested group sequential framework for regional evaluation in global drug development program

2017 ◽  
Vol 27 (6) ◽  
pp. 945-962
Author(s):  
William Wang ◽  
Zhiwei Jiang ◽  
Jingjun Qiu ◽  
Jielai Xia ◽  
Xiang Guo
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Group Sequential ◽  
Drug Development Program ◽  
Global Drug Development

Statistical Properties of the Design for Simultaneous Global Drug Development Program

2014 ◽  
Vol 25 (6) ◽  
pp. 1135-1144 ◽  
Author(s):  
Kezhen Liu ◽  
Zhilong Yuan ◽  
Gang Chen ◽  
Qin Huang ◽  
Judith Wenrich
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Statistical Properties ◽  
Drug Development Program ◽  
Global Drug Development

A Basic Study on Collaborative Plan of Translational Service Research for Accelerating New Drug Development

2014 ◽  
Vol 15 (1) ◽  
pp. 283-306
Author(s):  
Kim, Chang Won ◽  
Lee Cheol-Gyu ◽  
Youn Sung Kim ◽  
WangJin Yoo
Keyword(s):  
Drug Development ◽  
Service Research ◽  
Basic Study ◽  
New Drug ◽  
New Drug Development

scholarly journals New drug development

2011 ◽  
Vol 22 ◽  
pp. ii54-ii57
Keyword(s):  
Drug Development ◽  
New Drug ◽  
New Drug Development
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