Pharmaceutical Quality (Industry)
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Batch/Lot Information

Details about batches of the drug product and substance, with identifiers.

Product

Resources

Medicinal Product DefinitionThe drug product (Stelbat tablets, 20mg)
MedicationIdentifying information about the actual batches of the product (instances)

Examples

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML rendering of synthetic CTD data:

Substance

Resources

SubstanceDefinitionThe substance itself
SubstanceIdentifying information about the actual batches of the substance (instances)

Examples

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML rendering of synthetic CTD data: