Drug product stress testing

Figure 2 Drug product stress testing studies performed by phase of development (n= 18 first performed, n= 16 repeated).

Table 7.3 General protocol for stress testing of drug substances and drug products Stress condition...

Stress Testing (drug product) — Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing of certain products (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products). 

Stress testing is conducted to provide data on forced decomposition products and decomposition mechanisms for the drug substance. 

The ICH definition of stress testing for the drug product is shown below (7) ... 

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