Forced degradation studies stress testing

Table 1 General Protocol for Forced Degradation Studies (Stress Testing) of Drug Substance and Drug Products...

Recent publications on the topic of stress testing/forced degradation studies reveal that there is still a tremendous variability in the conditions... 

As described in the PhRMA Available Guidance and Best Practices article on forced degradation studies (12), stress testing should include condi-... 

The forced degradation studies should be part of impurity characterization. When identification of the impurity is not feasible, incorporate the description of unsuccessful experiments (including those conducted in stress-testing studies) in the text of the application. The most frequently encountered protein variants include truncated fragments, deamidated, oxidized, isomerized, aggregated forms, and mismatched disulfide links. 

Procedure or forms for investigating, reporting, corrective action Forced degradation/stress studies Material to be tested Conditions Extent of degradation Identification of degradants Switch to ICEI conditions Allowable circumstances Procedure... 

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