FAQ
Drugs
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No. Class Title
  221   Application of Bridging Study Evaluation (BSE)  

What clinical data should be provided in BSE submission?

 
  222   Application of Bridging Study Evaluation (BSE)  

When is the proper time to apply a BSE (Bridging Study Evaluation)?

 
  223   Application of Bridging Study Evaluation (BSE)  

What kinds of new drugs need to apply for evaluation of bridging studies? What are the required documents?

 
  224   Application of Bridging Study Evaluation (BSE)  

I’d like to conduct a bridging study in Taiwan. May I consult with CDE for the design of the bridging study?

 
  225   Postapproval Changes  

A dissolution profile comparison study is required to support post-approval changes (minor change as defined in the announcement of the Department of Health, No. 0900018043). What is the requirement for the batch size of the test product (post change)?

 
  226   Postapproval Changes  

For oral delayed-release product, when there involved minor change and dissolution test is needed, what are the requirements for dissolution document?

 
  227   Postapproval Changes  

If bio-batch is not used as reference product in the dissolution profile comparison study, what technical information will be needed to support formulation change, manufacturing site change, or multiple strengths bio-waiver in terms of quality consistency in between the reference product and bio-batch?

 
  228   Postapproval Changes  

What documentation should be submitted for post-approval manufacturing site change?

 
  229   Postapproval Changes  

If a bioequivalence study is required because of the formulation and manufacturing process of a product involving “major change”, which reference product should be used in the bioequivalence study?

 
  230   Postapproval Changes  

Why analytical method should be validated in each pH medium when performing multi-medium dissolution profile comparison studies?

 
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