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FAQs

What are API Quality Study Processes in the IND Phase?

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

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

3) Stability study (using pilot batch or safety assessment batch + GMP batch)
  Study of influencing factors (early stage testing using laboratory scale)
  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