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No. Class Title
  191   Abbreviated New Drug Application (ANDA)  

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

  
  192   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?

  
  193   Abbreviated New Drug Application (ANDA)  

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

  
  194   Abbreviated New Drug Application (ANDA)  

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

  
  195   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?

  
  196   Abbreviated New Drug Application (ANDA)  

If the license of a brand-name drug is revoked or cancelled, could the next application follow the regulations of generic drugs?

  
  197   Abbreviated New Drug Application (ANDA)  

According to Subparagraph 2 of Paragraph 1 of Article 4 of Regulations for Registration of Medicinal Products, a generic drug should contain the identical active ingredient(s), dosage form, strength and efficacy as the drug already approved in Taiwan. Is it necessary to have excipients be identical?

  
  198   Abbreviated New Drug Application (ANDA)  

What contents should be presented in CTD Module 1.15: Status of domestic Bioavailability (BA)/ Bioequivalence (BE) Study?

  
  199   Abbreviated New Drug Application (ANDA)  

Is it necessary to submit Common Technical Document (CTD) module 1 to 5 for the registration of generic drugs?

  
  200   Abbreviated New Drug Application (ANDA)  

What is the reference drug for a generic drug?

  
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