stability commitment
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- When available long term stability data on primary batches do not cover the proposed re-test period granted at the time of approval, a commitment should be made to continue the stability studies post approval in order to firmly establish the re-test period.
- Broader Term
- post approval commitment
- Related Term
- long term stability data
- primary batch
- stability study drug substance
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