Release 5 Preview #2
Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the AdministrableProductDefinition resource.

AdministrableProductDefinition
Element IdAdministrableProductDefinition
Definition

A pharmaceutical product described in terms of its composition and dose form.

Cardinality0..*
TypeDomainResource
Alternate NamesPharmaceutical Product
Summarytrue
AdministrableProductDefinition.identifier
Element IdAdministrableProductDefinition.identifier
Definition

An identifier for the pharmaceutical medicinal product.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
AdministrableProductDefinition.subject
Element IdAdministrableProductDefinition.subject
Definition

The product that this is a pharmaceutical product of.

Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
AdministrableProductDefinition.administrableDoseForm
Element IdAdministrableProductDefinition.administrableDoseForm
Definition

The administrable dose form, after necessary reconstitution.

Cardinality0..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.unitOfPresentation
Element IdAdministrableProductDefinition.unitOfPresentation
Definition

Todo.

Cardinality0..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.producedFrom
Element IdAdministrableProductDefinition.producedFrom
Definition

The manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solution item). Note that these are not raw ingredients.

Cardinality0..*
TypeReference(ManufacturedItemDefinition)
Summarytrue
AdministrableProductDefinition.ingredient
Element IdAdministrableProductDefinition.ingredient
Definition

The ingredients of this administrable pharmaceutical product.

Cardinality0..*
TypeReference(Ingredient)
Summarytrue
AdministrableProductDefinition.device
Element IdAdministrableProductDefinition.device
Definition

Accompanying device.

Cardinality0..*
TypeReference(DeviceDefinition)
Summarytrue
AdministrableProductDefinition.property
Element IdAdministrableProductDefinition.property
Definition

Characteristics e.g. a products onset of action.

Cardinality0..*
Summarytrue
AdministrableProductDefinition.property.type
Element IdAdministrableProductDefinition.property.type
Definition

A code expressing the type of characteristic.

Cardinality1..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.property.value[x]
Element IdAdministrableProductDefinition.property.value[x]
Definition

A value for the characteristic.

Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
AdministrableProductDefinition.property.status
Element IdAdministrableProductDefinition.property.status
Definition

The status of characteristic e.g. assigned or pending.

Cardinality0..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration
Element IdAdministrableProductDefinition.routeOfAdministration
Definition

The path by which the pharmaceutical product is taken into or makes contact with the body.

Cardinality1..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.code
Element IdAdministrableProductDefinition.routeOfAdministration.code
Definition

Coded expression for the route.

Cardinality1..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.firstDose
Element IdAdministrableProductDefinition.routeOfAdministration.firstDose
Definition

The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement.

Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxSingleDose
Element IdAdministrableProductDefinition.routeOfAdministration.maxSingleDose
Definition

The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement.

Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxDosePerDay
Element IdAdministrableProductDefinition.routeOfAdministration.maxDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation.

Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Definition

The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation.

Cardinality0..1
TypeRatio
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod
Definition

The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation.

Cardinality0..1
TypeDuration
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies
Definition

A species for which this route applies.

Cardinality0..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Definition

Coded expression for the species.

Cardinality1..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod
Definition

A species specific time during which consumption of animal product is not appropriate.

Cardinality0..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Definition

Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk.

Cardinality1..1
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Definition

A value for the time.

Cardinality1..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Definition

Extra information about the withdrawal period.

Cardinality0..1
Typestring
Summarytrue