No. Class Title
  101   New Drug Application (NDA)  

What are the review points for PK technical documents in a NDA submission (as a new chemical entity)?

  102   New Drug Application (NDA)  

Is there any point of view about developing IV bolus administered method in low oral bioavailability drug based on the result of animal study?

  103   New Drug Application (NDA)  

For the new drug applications of controlled release dosage form contained multiple dose strengths. Under the proportionally similar formulations of different dose strengths product and the known linear PK characteristics in IR product, is it necessary to perform a PK study in all different dose strengths?

  104   New Drug Application (NDA)  

Is it acceptable to submit a new drug application for a drug product involving two or more drug substance manufacturers?

  105   New Drug Application (NDA)  

If the drug substance is fermented by microorganisms (e.g., bacteria, yeast, fungi or microalgae, etc.), should the identification of microorganisms be provided?

  106   New Drug Application (NDA)  

When class 2 solvents are used in the manufacturing process of drug substance, what information should be provided if the absence of a routine test for class 2 solvents in the drug substance?

  107   New Drug Application (NDA)  

Is it acceptable to use an overage of a drug substance to compensate for degradation during a drug product‘s shelf life?

  108   New Drug Application (NDA)  

Should physicochemical properties of drug substance be provided in technical documentation of the drug substance?

  109   New Drug Application (NDA)  

Should the drug substance manufacturing process be provided in technical documentation of the drug substance?

  110   New Drug Application (NDA)  

What is primary reference standard?

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