combined pharmaceutical dose form
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Definition
- single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product, and that includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product EXAMPLE Powder and solvent for solution for injection. The Medicinal Product contains two manufactured items: a powder for solution for injection and a solvent for solution for injection. The pharmaceutical product that is prepared from the two manufactured items is a solution for injection; the combined pharmaceutical dose form for the Medicinal Product is “powder and solvent for solution for injection”.
- Related Term
- administrable dose form
- combined term
- manufactured dose form
- pharmaceutical dose form
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