Compatibility

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. For a full list of available versions, see the Directory of published versions

Details about compatibility studies and results.

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Medication	Describes the batches that underwent testing
Ingredient	The active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinition	Chemical or biological details about substance(s) associated with the ingredient
PlanDefinition	Describes the compatibility analysis protocol
ObservationDefinition	Each individual test and acceptance criteria; also used to group tests
Observation	The results of a specific test mentioned in the ObservationDefinition
DiagnosticReport	Contains all results as a group and captures conclusions

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).