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FAQs

What are API Quality Study Processes in IND Phase?

1) Development of analytical method (starting materials, intermediates, API, Middle controlled Analysis, preliminary degradation tests)

2) Validation of analytical method (use pilot batch samples, if no pilot batch, use safety assessment batch)

3) Stability study (pilot batch or safety assessment batch + GMP batch)
  Influence factor study (in early stage, use Laboratory scale for pre-influencing factor test)
  Accelerated stability study (6 months)
  Long-term stability study (24 months or extended to 36 months)

4) Preparation and writing of declaration documents in CTD format