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  131   New Drug Application (NDA)  

【Clinical】What are the points for consideration when reviewing new drug application (NDA) from efficacy aspect?

  
  132   New Drug Application (NDA)  

【Clinical】What are the points for consideration when reviewing new drug application (NDA) from safety aspect?

  
  133   Investigational New Drug Application(IND)  

【Pharm/Tox】The sponsors need to provide nonclinical pharmacology/toxicology data and nonclinical pharmacokinetic data when applying the first-in-human clinical study. Does the full report of each nonclinical study need to be submitted besides the investigator’s brochure?

  
  134   Investigational New Drug Application(IND)  

What technical document regarding Chemistry, Manufacturing, and Controls (CMC), pharmacokinetics (PK), and pharmacology/toxicology (PT) should be submitted for radiopharmaceuticals in investigational new drug (IND) applications?

  
  135   Investigational New Drug Application(IND)  

【BIO】How to perform the identification tests for stem cells?

  
  136   Investigational New Drug Application(IND)  

【BIO】Does the autologous cell therapy product not need to perform donor screening or donor testing?

  
  137   Investigational New Drug Application(IND)  

【BIO】Could the adventitious virus test only be performed in donor testing since the cells number in autologous cell therapy products is limited?

  
  138   Investigational New Drug Application(IND)  

【BIO】Could the medicinal products from the same marketing authorization holder rather than the registered manufacturer be used as reference materials for developing biosimilar?

  
  139   Investigational New Drug Application(IND)  

【BIO】Should the excipients and primary packaging materials used in biosimilar be the same as the brand name drugs?

  
  140   Investigational New Drug Application(IND)  

What is the PK/PD point of view in IND application?

  
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