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which are the guidelines for force degradation studies?



which are the guidelines for force degradation studies?..

Answer / praveen kumar_ipca

The ANVISA forced degradation study requirements have an expansion of forced degradation beyond the work already performed during the various stages of drug and formulation development. This differs from the approaches adopted by ICH, EMA & FDA guidelines.

Praveen Kumar
IPCA
Sr.Excurive

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