new drug substance
- Guideline or reference source
- ICHQ3A Impurities in new drug substances
- ICHQ3B Impurities in new drug products
- ICHQ6A Specifications: new chemical drug substances and products
- Definition
- The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved drug substance.
- Used For
- NAS
- new active substance
- Broader Term
- drug substance
- Related Term
- development substance
- moiety
- new drug product
- new molecular entity
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