FAQ
Drugs
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No. Class Title
  181   Investigational New Drug Application(IND)  

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

 
  182   Investigational New Drug Application(IND)  

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

 
  183   Investigational New Drug Application(IND)  

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

 
  184   Investigational New Drug Application(IND)  

【Clinical】What components should a study protocol include?

 
  185   Abbreviated New Drug Application (ANDA)  

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

 
  186   Abbreviated New Drug Application (ANDA)  

What dosage form of generic drugs can be exempt from the bioequivalence study?

 
  187   Abbreviated New Drug Application (ANDA)  

What are the requirements for bioequivalence study and clinical trials of generic drugs with active ingredients on the list of post marketing surveillance (including those within the pharmacovigilance period and those pharmacovigilance period has expired)?

 
  188   Abbreviated New Drug Application (ANDA)  

Which CTD section should the analytical method validation report of the dissolution profile comparison report be presented?

 
  189   Abbreviated New Drug Application (ANDA)  

Which CTD section should the dissolution profile comparison report for additional strength bio-waiver be presented?

 
  190   Abbreviated New Drug Application (ANDA)  

Which CTD section should I place the BA/BE study reports and their relevant clinical document?

 
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