ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Stress Testing (drug product)

(ICH Q1A (R2)) Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing on certain products, (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products).

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