FAQ
Drugs
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No. Class Title
  181   Abbreviated New Drug Application (ANDA)  

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

 
  182   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)?

 
  183   Abbreviated New Drug Application (ANDA)  

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

 
  184   Abbreviated New Drug Application (ANDA)  

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

 
  185   Abbreviated New Drug Application (ANDA)  

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

 
  186   Abbreviated New Drug Application (ANDA)  

Which CTD section should the reports of bioanalytical and analytical methods for human PK study be presented?

 
  187   Abbreviated New Drug Application (ANDA)  

For the bioequivalence study of highly variable drug, in what circumstances that the 90% CI of the Cmax can be widened to 0.75~1.33?

 
  188   Abbreviated New Drug Application (ANDA)  

What document should be submitted for system suitability of the dissolution assembly in the dissolution profile comparison report?

 
  189   Abbreviated New Drug Application (ANDA)  

How to set the linearity range of the dissolution test method for dissolution profile comparison study?

 
  190   Abbreviated New Drug Application (ANDA)  

If an ICH Q3C Class II solvent is used in a drug substance manufacturing process, how should the limit on the residual solvent be specified?

 
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