manufactured dose form
- Guideline or reference source
- EDQMST General principles and instructions for use of the list of standard terms
- ISO11239 IDMP Data elements and structures for the unique identificaiton and exchange of regulated information on pharmaceutical dose forms , units of presentation, routes of administration and packaging
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation into the pharmaceutical product EXAMPLE Powder for solution for injection. NOTE The manufactured dose form is identical to the administrable dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product).
- Broader Term
- pharmaceutical dose form
- Related Term
- administrable dose form
- combined pharmaceutical dose form
- drug product
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