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Qsauri
"N"

new drug product
Guideline or reference source
ICHQ6A Specifications: new chemical drug substances and products
Definition
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients.
Related Term
new drug substance
new molecular entity
 

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