| Application Code
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Application Code for the Application associated with the PDS.
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| Application Name
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Application Name for the Application associated with the PDS.
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| Biotechnology Origin
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The biological source such as bovine, feline, etc..
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| Compendial Designation/Source
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Designation related to Pharmacopoeia. For example: USP, PhEUR, JP.
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| Component Name
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Component Name associated with the PDS.
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| Composition Grouping Description
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Description of composition grouping for the substance. You cannot modify the description after saving.
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| Date QC'd
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The date the QC Status was set.
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| Drug Safety Alerts
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Items related to drug safety information.
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| Family Code
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Product Family Code associated with the PDS.
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| Family Name
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Product Family Name associated with the PDS.
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| High Amount Denominator Prefix
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The high limit denominator prefix for range measurements.
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| High Amount Denominator Unit
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The high limit denominator unit for range measurements.
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| High Amount Denominator Value
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The high limit denominator value for range measurements.
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| High Amount Numerator Prefix
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The high limit numerator prefix for range measurements.
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| High Amount Numerator Unit
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The high limit numerator unit for range measurements.
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| High Amount Numerator Value
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The high limit numerator value for range measurements.
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| Include Concentrations to XEVMPD?
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Used to include or exclude concentration data in XEVMPD submission XML file.
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| Low Amount Denominator Prefix
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The low limit denominator prefix or for non-range measurements the denominator prefix.
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| Low Amount Denominator Unit
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The low limit denominator unit or for non-range measurements the denominator unit.
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| Low Amount Denominator Value
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The low limit denominator value or for non-range measurements the denominator value.
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| Low Amount Numerator Prefix
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The low limit numerator prefix or for non-range measurements the numerator prefix.
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| Low Amount Numerator Unit
|
The low limit numerator unit or for non-range measurements the numerator unit.
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| Low Amount Numerator Value
|
The low limit numerator value or for non-range measurements the numerator value.
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| Measurement Point
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The physical or logical location at which a condition is described.
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| Concentration Measure Type
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Used with other attributes to specify information about the concentration of the substance. Values:
Equal,
Range,
Up to, or
Not Less Than.
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| Presentation Single or Low Limit Numerator Value
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The Presentation Single or Low Limit Numerator Value for the Substance.
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| Presentation Single or Low Limit Unit of Measurement
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The unit of measurement for the Presentation Single or Low Limit Numerator Value.
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| Presentation Single or Low Limit Unit of Presentation
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The unit of presentation for the Presentation Single or Low Limit Numerator Value.
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| Presentation High Limit Numerator Value
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The Presentation High Limit Numerator Value for the Substance.
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| Presentation High Limit Unit of Measurement
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The unit of measurement for the Presentation High Limit Numerator Value for the Substance.
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| Presentation High Limit Unit of Presentation
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The unit of presentation for the Presentation High Limit Numerator Value for the Substance.
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| Concentration Single or Low Limit Numerator Value
|
The Concentration Single or Low Limit Numerator Value for the Substance.
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| Concentration Single or Low Limit Unit of Measurement
|
The unit of measurement for the Concentration Single or Low Limit Numerator Value.
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| Concentration Single or Low Limit Denominator Value
|
The Concentration Single or Low Limit Denominator Value for the Substance.
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| Concentration Single or Low Limit Unit of Measurement
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The unit of measurement for the Concentration Single or Low Limit Denominator Value.
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| Concentration High Limit Numerator Value
|
The Concentration High Limit Numerator Value for the Substance.
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| Concentration High Limit Unit of Measurement
|
The unit of measurement for the Concentration High Limit Numerator Value.
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| Concentration High Limit Denominator Value
|
The Concentration High Limit Denominator Value for the Substance.
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| Concentration High Limit Unit of Measurement
|
The unit of measurement for the Concentration High Limit Denominator Value.
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| Product Detail Set Name
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The name of the PDS associated with this detail. Displayed as (PDS Name + PDS Code).
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| Product Name
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The name of the product associated with this detail. Displayed as (Product Name + Product Strength + Product Dosage Form +Product Code).
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| Origin of Substance
|
Name of the substance source. You cannot modify the value after saving.
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| QC Status
|
QC Status of the detail.
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| QC'd by
|
Person logged on to the system who set the QC Status for the detail to
QC Passed or
QC Failed.
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| Sort Substance
|
The ability to select the menu option and re-order the Substances.
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| Substance Comments
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Additional text about the entity.
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| Substance Description
|
Free format text box for entering descriptive information.
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| Substance Keywords
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Free format text box where users can enter text for searching purposes.
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| Substance Name
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The name of the substance.
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| Substance Role
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The purpose of the substance.
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| Substance Status
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Status of the detail - non configurable - values are
Pending,
Approved,
Not Approved.
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| Substance Status Date
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Current date for substance status.
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| Substance Type
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Classifies the type of substance such as excipient, adjuvant, allergen, etc.
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| Use as Active Ingredient for XEVMPD
|
Identifies if the current Substance Detail will be used as an Active Ingredient in the XEVMPD XML creation via the
XEVMPD Submission Wizard.
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