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IND application (General Introduction to US IND (why-讓試驗藥物從臨床前試驗進入人體臨床試驗 …

- - - - •Drug substance
      - •Drug product
      - •Placebo
      - •Literature references
    - - •Form FDA 1571, 3792, 3674
        
        1571-the sponsor
      - •Environment assessment or exclusion claim
      - •Investigational drug labels
      - •Pre-IND correspondence
      - •Pediatric study information
      - •General investigational plan
        
        方法/受試者人數/族群/適應症/可能風險
      - IB
        
        計畫主持人的百科全書
    - - •Introductory statement
        
        藥品基本資料
      - •Quality overall summary
      - •Nonclinical overview
      - •Clinical overview
      - •Nonclinical written and tabulated summaries
      - •Clinical summary
      - •Drug dependence and abuse
    - - •Nonclinical study reports
        
        toxicology
      - •Literature references
    - - •Clinical protocol (s)
        
        COMMON PROBLEMS IN PROTOCOL
      - •Form(s) FDA 1572 or equivalent description (s) of investigator (s), site (s) and IRB(s)
        
        investigator acknowledge legal responsibility and obligation
      - •Clinical study reports
      - •Literature references