Lek's Approach to CAANDAs

Abstract

To date, the pharmaceutical industry has focused primarily on document management and systems associated with electronic or computer assisted new drug applications (CANDAs). While generic drugs represent a large segment of the Food and Drug Administration's (FDA) work, not much has been reported about computer assisted abbreviated new drug applications (CAANDAs). For development of LEK's CAANDA system, standard hardware and software were primarily used, including a Windows environment on an IBM-PC platform. LEK's CAANDAs consist of three main components: control shell, file viewer, and text searcher. Criteria for choosing the appropriate software, choices made, and a brief description of their functions are included. The way in which the experimental system was implemented in practice and the initial results of the new way of working are also described. This system, being simple and inexpensive, can be used for preparing registration documentation for various drugs and formulations for any country's registration. The system can also serve as the core document management system for use by the whole company.