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Pre-IND Preparation

  • Assembly of documentation
    • Evaluation of drug substance
    • Evaluation of GMP manufacturing and quality controls
    • Evaluation of a preclincal plan
    • Evaluation of the clinical safety study
  • Request for meeting
  • Arrange and coordinate the meeting

 

 

 

 

 

 

 


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     Last Updated Jan 25, 2010

 

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