Mary Sommer,Mark Ammann,Ulf B. Hillgren,Kathleen J. Kovacs,Keith D. Wilner
标识
DOI：10.1002/9780470613191.ch14
摘要
This chapter contains sections titled: Introduction Submission Strategies First-in-Human Dossiers United States: Investigational New Drug Application European Union: Clinical Trial Application Japan: Clinical Trial Protocol Notification Emerging Regions Biopharmaceuticals Final Considerations
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