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  161   Investigational New Drug Application(IND)  

【ST】What are the statistical review considerations for interim analysis of a clinical trial?

  
  162   Investigational New Drug Application(IND)  

【ST】What are the review considerations for statistical analysis in clinical trials?

  
  163   Investigational New Drug Application(IND)  

【ST】What are the review considerations for the missing data in clinical trials?

  
  164   Investigational New Drug Application(IND)  

【ST】What are the review considerations for efficacy and the safety analysis population of clinical trials?

  
  165   Investigational New Drug Application(IND)  

【ST】What are the review considerations for the statistical margin in clinical trials?

  
  166   Investigational New Drug Application(IND)  

【ST】What are the statistical review considerations for the design of clinical trials?

  
  167   Investigational New Drug Application(IND)  

【ST】What are the statistical review considerations for the primary endpoint?

  
  168   Investigational New Drug Application(IND)  

【ST】What are the statistical considerations for review of investigational new drug (IND) applications?

  
  169   Investigational New Drug Application(IND)  

【Pharm/Tox】For an investigational new drug (IND), is it necessary to evaluate the safety of the excipients which exceed the approved range?

  
  170   Investigational New Drug Application(IND)  

【Pharm/Tox】Nonclinical studies-Should the reproductive and developmental toxicity study be completed before the application of phase I IND?

  
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