stress testing, drug product
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- 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).
- Narrower Term
- photostability testing
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