Preparation of Bulk Drug for the U.S. Army Drug Development Program

2001 ◽  
Author(s):  
Jaroslav Novotny
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Bulk Drug ◽  
Drug Development Program ◽  
The U.S

The U.S. Army Drug Development Program

Chemotherapy ◽  
1979 ◽  
pp. 99-108
Author(s):  
Craig J. Canfield ◽  
Melvin H. Heiffer
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Drug Development Program ◽  
The U.S

Preparation of Chemical Compounds for the U.S. Army Drug Development Program

1990 ◽  
Author(s):  
P. Blumbergs ◽  
L. V. Dunkerton ◽  
B. S. Ross ◽  
D. A. Greening ◽  
D. J. Dagli ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Chemical Compounds ◽  
Drug Development Program ◽  
The U.S

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.

Abstract B54: Current intervention strategies in the NCI PREVENT Cancer Preclinical Drug Development Program

2015 ◽  
Author(s):  
Robert H. Shoemaker ◽  
Barbara K. Dunn ◽  
Chen Suen ◽  
Dan L. Boring ◽  
Brian D. Klein ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Intervention Strategies ◽  
Preclinical Drug Development ◽  
Drug Development Program
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