Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Compatibility

Details about compatibility studies and results.

Product

Resources

MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
MedicationDescribes the batches that underwent testing
IngredientThe active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient
PlanDefinitionDescribes the compatibility analysis protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group tests
ObservationThe results of a specific test mentioned in the ObservationDefinition
DiagnosticReportContains all results as a group and captures conclusions

Examples

CTD section samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

  • Drug Product Compatibility - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

Profiles

See Artifacts Index: Domain Bundle Profiles