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  131   Investigational New Drug Application(IND)  

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

  
  132   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?

  
  133   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?

  
  134   Investigational New Drug Application(IND)  

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

  
  135   Investigational New Drug Application(IND)  

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

  
  136   Investigational New Drug Application(IND)  

There has been a modified-release product with the same active ingredient approved in Taiwan. For a new modified-release type product with the same administration route, is it acceptable to conduct a BE study design in its NDA package? 【This question is not applicable to liposome, transdermal formulations and nano formulations】

 
  137   Investigational New Drug Application(IND)  

In the development of a biosimilar product, what studies should be conducted if the manufacturing site of the reference product in PK/PD comparability study is not the same as the Taiwanese approved product?

  
  138   Investigational New Drug Application(IND)  

What kind of preclinical PK data should be provided when applying for the first-in-human (FIH) IND?

  
  139   Investigational New Drug Application(IND)  

What kind of preclinical PK/PD studies could be waived for the Botanical IND application?

  
  140   Investigational New Drug Application(IND)  

For ongoing clinical trials, the composition of the drug product is changed and what CMC data should be submitted?

  
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