Company Investigational Drug Was Handled As Marketed Company Drug
(Doc ID 2488363.1)
Last updated on FEBRUARY 24, 2019
Applies to:Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.
When the following scenario,
Second G.k.2.2 is displayed as UNKNOWNDRUG.
It means Argus considers other company drug
Steps to Repeat:
1) Create a Foregin case
Report type = Report from Study
Not blinded study
2) Set the case: Two proucts under product tab
Primary is Study drug
Secondary is investigational drug but not in the Study design product
Drug code should be blank
3) Set teh case: Under PMDA tab, there are four licenses are displayed
- #1 and #2 comes from 1st product. And there are MKT and INV license
- #3 and #4 comes from 2nd product. And there are two INV licenses which have clinical compound number in the Console
4) Generate MKT report
- Second G.k.2.2 is displayed as UNKNOWNDRUG. It means Argus considers other comapany drug
In the scenario, 2nd product has to be
considered as company product because there are japan licenses for the
product configured in console.
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