Abstract
Wyeth-Ayerst's venlafaxine submission included 29 studies and 2,897 patients in the Phase II and III depression grouping. This global submission also included a computer assisted new drug application that was produced in-house. A “superstructure” database in Oracle was used for processing reports and ad-hoc queries, significantly reducing the necessary time and resources, as well as minimizing the errors and frustration that normally occur, in the preparation of global integrated safety reports.
This paper outlines some of the successful processing strategies used to generate standard data processing reports and ad-hoc queries during the approval process. Two key approaches are discussed: 1. processing strategies used in the “superstructure” database, including storing of derived variables, and 2. streamlining the processing of a series of reports for consistency, including the use of SAS macros.
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