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A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process

A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process AbstractThis primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of the American Medical Informatics Association Oxford University Press

A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process

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References (12)

Publisher
Oxford University Press
Copyright
American Medical Informatics Association
ISSN
1067-5027
eISSN
1527-974X
DOI
10.1136/jamia.1998.0050432
Publisher site
See Article on Publisher Site

Abstract

AbstractThis primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure.

Journal

Journal of the American Medical Informatics AssociationOxford University Press

Published: Sep 1, 1998

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