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  61   Abbreviated New Drug Application (ANDA)  

If the long-term and accelerated stability data in low humidity condition of aqueous-based products packaged in semi-permeable containers were provided, should water loss evaluation still be assessed?

  
  62   Abbreviated New Drug Application (ANDA)  

The analytical method of related substances for drug substance is by HPLC. Is it necessary to prepare the standard solution with the same concentration as that of 100% impurity specification?

  
  63   Abbreviated New Drug Application (ANDA)  

Nitrogen filled in injections does not react with drug product and is not absorbed by human body. Is it necessary to be listed in the composition statement in the application form?

  
  64   Abbreviated New Drug Application (ANDA)  

According to Regulations for Registration of Medicinal Products, Article 9-4, specifications and test methods should be provided for coloring agents. However, if the coloring agents are components of hard capsules, are the specifications and test methods for the coloring agents still required in the drug product application?

  
  65   Abbreviated New Drug Application (ANDA)  

Regarding an acceptance criterion of "water content" specified for drug product, could it be established by the upper one-sided and lower one-sided 95% confidence limit at the end of shelf life with 6-month data of "water content" in long-term and accelerated stability?

  
  66   Abbreviated New Drug Application (ANDA)  

When performing uniformity of dosage units test for a tablet of combination drug, is it acceptable to take the lowest dosage unit component as the worst case to represent the uniformity of the drug product?

  
  67   Abbreviated New Drug Application (ANDA)  

A pilot scale for solid oral dosage forms is generally not less than 100,000 finished dosage units, which is mentioned in “Guideline on Stability Testing of Drug Substances and Products” (MOHW No.1041408733) announced on 11th March 2016. Can 10 percent of the proposed production batch size of the finished product for the dosage forms, except solid oral and special pharmaceutical dosage forms, be considered as a pilot scale batch size to support the stability of ANDA submission?

  
  68   Abbreviated New Drug Application (ANDA)  

A tablet with total weight 100 mg contains 50 mg of drug substance (50% w/w). Can the uniformity of dosage units test be demonstrated by weight variation test in the specification for finished product?

  
  69   New Drug Application (NDA)  

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?

  
  70   Abbreviated New Drug Application (ANDA)  

Is a structural characterization and/or safety data required for 3.2.S.3.2 Impurities section of ANDA submission?

  
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