Add Drug Label Evidence
Use Drug Label evidence to support Predictive associations.
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1.
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In the Evidence panel, select the Add New Evidence drop-down arrow, and then select Drug Label. |
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2.
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Enter the drug brand in the Brand field. |
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3.
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Enter the drug uses in the Uses field. |
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4.
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Select the Authorizing Authority drop-down arrow, and then select one of the following options: |
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FDA—Food and Drug Administration |
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EMA—European Medicines Agency |
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HCSC—Health Canada (Santé Canada) |
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PMDA—Pharmaceutical and Medical Devices Agency |
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5.
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[Optional] Enter the following information about the drug: |
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Enter the therapeutic area in the Therapeutic Area field. |
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Enter the purpose in the Purpose field. |
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Enter the active ingredient in the Active Ingredient field. |
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Enter the biomarker in the Biomarker field. |
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6.
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Select the Support Type drop-down arrow, and select a support type. The list of support types varies based on the association type. |
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7.
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Select the Evidence Strength drop-down arrow, and then select an evidence strength. Refer to ACMG Standards and Guidelines for classification criteria. |
NOTE
ACMG Supporting strength is equivalent to BaseSpace Variant Interpreter Weak strength.
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8.
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[Optional] Enter a summary of the evidence in the Evidence Summary field. |