reference strength
- Guideline or reference source
- 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
- strength of substance(s) and/or specified substance(s) used as a reference from which the strength of an investigational or authorized Medicinal Product is described EXAMPLE 1 Where an ingredient is present in the form of a salt or hydrate, the quantitative composition may be expressed in terms of the mass [or biological activity in International (or other) units where appropriate] of the active moiety (base, acid or anhydrous material), e.g. ‘60 mg toremifene (as citrate)’ or ‘toremifene citrate equivalent to 60 mg toremifene’ will have ‘toremifene citrate’ as the active ingredient and ‘toremifene’ as the reference substance. EXAMPLE 2 Where the active ingredient is an ester or pro-drug the quantitative composition may be stated in terms of the quantity of that ester or pro-drug; e.g. 75 mg of fosphenytoin, which is equivalent to 50 mg of phenytoin. ‘Phenytoin’ is therefore the reference substance. NOTE The strength of the substance(s) and/or specified substance(s) shall be described as a quantity of the substance present in a given unit of the pharmaceutical product or manufactured item.
- Broader Term
- strength
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