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