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Details about drug substance or drug product release and stability specification (tests, acceptance criteria).
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| MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
| 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 specification set of tests |
| ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests |
| 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 which this is a specification for |
| PlanDefinition | Describes the specification set of tests |
| ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data: