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Provide details about drug substance and drug product components, materials, and Quality reference standards.
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| MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
| Ingredient | The active ingredient (stelbatalol) and other ingredients that make up the product |
| SubstanceDefinition | The documented impurities |
| PackagedProductDefinition | Information about the packaging for the product |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data:
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| SubstanceDefinition | The substance for which reference standards are being established |
| Substance | Identifying information about an actual batch of substance (an instance) |
| PlanDefinition | Describes the reference standards set of tests |
| ObservationDefinition | Each individual test and acceptance criteria |
| Observation | The results of a specific test mentioned in the ObservationDefinition |
| DiagnosticReport | Contains all results as a group and captures conclusions |
| Organization | (not illustrated above): The company/site that performed the testing or manufacturing |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data: