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

What is a generic drug?

  202   CIRB  

What are the requirements for c-IRB review?

  203   CIRB  

What is c-IRB??

  204   Botanical drug  

There is no guideline about good agricultural and collection practice (GACP) in Taiwan at present. Which GACP guidelines could be followed, the World Health Organization’s “WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants” or the European Medicines Agency’s “Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin”?

  205   Botanical drug  

What are the requirement for selection of the stability batches for botanical drug products in an new drug application?

  206   Botanical drug  

With respect to good manufacturing practices (GMP) certified manufacturers, what documents for good agricultural and collection practices (GACP) are required to apply for a drug master file (DMF) when the drug substances use botanical raw materials from non-good agricultural practices (non-GAP) certified suppliers ?

  207   Botanical drug  

For safety pharmacology of botanical new drugs, are there clear “when & what” requirements, i.e., what kinds of information about previous human experience that can be applied to replace certain safety pharmacology studies?

  208   Botanical drug  

Botanical new drugs may be developed based on traditional medicines. Therefore, human experience of the active ingredients already exists. If the dosage of active ingredient in the botanical new drug is less than what has been used traditionally, is it possible to simplify (or reduce) nonclinical studies?

  209   Botanical drug  

According to the regulations of Taiwan and US, the requirements of early clinical studies are less strict. These requirements become much stricter in Phase III studies. In order to smoothen drug development, is it appropriate to prepare early IND package as close to Phase III requirements as possible?

  210   Botanical drug  

Could a botanical new drug be regarded as a generic drug due to long term previous human experiences? Could there be any different requirements during the new drug evaluation in CMC and PK aspects?

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