new molecular entity
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance.
- Abbreviation for
- NME
- Related Term
- new drug product
- new drug substance
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