novel excipient
- Guideline or reference source
- EMEA/CHMP/QWP/396951/2006 GUIDELINE ON EXCIPIENTS IN THE DOSSIER FOR APPLICATION FOR MARKETING AUTHORISATION OF A MEDICINAL PRODUCT
- Definition
- A novel excipient is an excipient which is being used for the first time in a drug product, or by a new route of administration (ICH). It may be a new chemical entity or a well established one which has not yet been used for human administration and /or for a particular human administration pathway in the EU and/or outside the EU.
- Broader Term
- excipient
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