active substance
- Guideline or reference source
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
- Used For
- active ingredient
- active pharmaceutical ingredient
- Broader Term
- substance
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