jodischneider
commented
8 years ago Going forward, for the new annotations, Katrina will be annotating clinical data coming from clinical studies as such, regardless of the source. Reference may be to a drug label, scientific paper, etc.
For retrospective assertions that have type "non-traceable drug label": 1) Change to "non-traceable statement" with Reference to the drug label.
Format for drug label reference: Lexapro (escitalopram oxalate) tablet, film coated/liquid [package insert]. St. Louis, MO: Forest Laboratories, Inc.; 2011 May. Set ID: D174F2B8-FEE2-4817-AD6C-364A1880E24B.http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=d174f2b8-fee2-4817-ad6c-364a1880e24b. Last Accessed: August 26, 2015.
2) Manually review: Clinical study (Y/N) 3) If Y: manual annotation 4) If N: Link to the New Drug Application
Non-traceable drug label and PK studies are not exclusive. This requires an update to both the data & model.
1) Add "drug label" as a subclass of Reference.
2) For all Non-traceable-drug-label-statements, associate with a "drug label" Reference
3) If PKDDI data/study for a drug-label, change the evidence type from Non-traceable-drug-label-statement to PKDDI. (Manual curation to be done by Sam.)
(This is needed for the query: "How many pharmacokinetic studies used for evidence items in the DIKB could be used to support or challenge an assertion about pharmacokinetic parameter X (e.g., `X increases AUC')?")