Project Management and International Regulatory Requirements and Strategies for First-In-Human Trials

Early Drug Development: Strategies and Routes to First-in-Human Trials

Volumn , Issue , 2010, Pages 513-541

  Finkle, Carolyn D ^a   Atkins, Judith ^b  

^a MEDIMMUNE   (United States)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

IND submission in united states and global clinical trials; Product development initiation with the end in mind; Project management and international regulatory requirements and strategies for first in human trials

Indexed keywords

EID: 84883903361     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470613191.ch13     Document Type: Chapter

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