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Brazil forced degradation study requirements


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Dear All,

I would like to ask a regulatory advice from you regarding the Brazil forced degradation study requirements.

Our idea on FDS would be not to follow step-by-step the ANVISA FDS Guideline; however to prove the suitability of analytical methods for the analysis of potential degradation products as well as to establish the knowledge on the chemical decomposition.

In this regard regulatory questions would be that:

  • How much can we deviate from the ANVISA FDS guideline?
  • Is it necessary to follow it step-by-step and should we perform all measurements?
  • Or, alternatively, is it possible to skip some measurements?
  • Is it possible to skip certain measurements, if we can find adequate literature data to support our application?
  • Is it possible to skip certain measurement if we can provide theoretical arguments that some measurements are scientifically not meaningful (degradation product cannot be generated based on theoretical arguments)
looking for your kind advice on the above mentioned questions.

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