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Details about test methods used to analyze substances and products, including compendial and non-compendial testing.
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| MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
| SubstanceDefinition | Substances used during the analysis process |
| PlanDefinition | Describes the analysis process |
| SpecimenDefinition | Describes the storage conditions and duration for each test |
| Observation Definition | Each individual analysis test and acceptance criteria; also used to group tests |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation examples of synthetic quality data:
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| SubstanceDefinition | Substances to be analyzed and also ones used during the analysis process |
| PlanDefinition | Describes the analysis process |
| DeviceDefinition | Devices/equipment used during testing |
| SpecimenDefinition | Describes the storage conditions and duration for each test |
| Observation Definition | Each individual analysis test and acceptance criteria; also used to group tests |
CTD section samples (PDF):
XML and JSON examples of synthetic quality data:
HTML rendering of synthetic quality data: