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  171   Investigational New Drug Application(IND)  

【Pharm/Tox】What non-clinical studies should be performed on an investigational new drug (IND) before applying for clinical trials?

  
  172   Investigational New Drug Application(IND)  

【Clinical】What are the clinical review considerations for other studies (PK/PD, PG study) and extension study?

  
  173   Investigational New Drug Application(IND)  

【Clinical】What are the review considerations for restrictions on "concomitant drugs" in clinical trials?

  
  174   Investigational New Drug Application(IND)  

【Clinical】What are the review considerations for the efficacy endpoints?

  
  175   Investigational New Drug Application(IND)  

【Clinical】What are the review considerations for " treatment period, observation period, and time points of visits " for clinical trials?

  
  176   Investigational New Drug Application(IND)  

【Clinical】What are the review considerations for "selection of dose, administration method " for clinical trials?

  
  177   Investigational New Drug Application(IND)  

【Clinical】What are the clinical review considerations for protection of clinical trials subjects?

  
  178   Investigational New Drug Application(IND)  

【Clinical】What are the review considerations for the "Inclusion criteria and exclusion criteria" of a clinical trial?

  
  179   Investigational New Drug Application(IND)  

【Clinical】What components should a study protocol include?

  
  180   Abbreviated New Drug Application (ANDA)  

What are the requirements for selecting the reference product for the bioequivalence study of generic drug?

  
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