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Details about drug substance and drug product batch release testing and results.
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| 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 batch 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 |
| 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:
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| SubstanceDefinition | The substance being tested |
| Substance | Identifying information about an actual batch of substance being tested (an instance) |
| PlanDefinition | Describes the batch 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 |
| 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: