Forced Degradation Studies for Drug Substances and Drug Products – A Regulatory Considerations
Forced Degradation Studies for Drug Substances and Drug Products – A Regulatory Considerations
Various regulatory guidance is available which provides useful definitions and general comments about degradation studies. However, guidance concerning the scope, timing, degradation condition, and best practices for degradation studies is very general. Various issues related to stress testing are addressed in numerous guidance documents but not always in the context of stress testing. Therefore, stress-testing conditions should be realistic and not excessive.
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