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

Identifieur interne : 000176 ( Pmc/Corpus ); précédent : 000175; suivant : 000177

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

Auteurs : Kip Canfield ; Michele Ritondo ; Richard Sponaugle

Source :

RBID : PMC:61324

Abstract

This 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.


Url:
PubMed: 9760391
PubMed Central: 61324

Links to Exploration step

PMC:61324

Le document en format XML

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<name sortKey="Ritondo, Michele" sort="Ritondo, Michele" uniqKey="Ritondo M" first="Michele" last="Ritondo">Michele Ritondo</name>
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<name sortKey="Sponaugle, Richard" sort="Sponaugle, Richard" uniqKey="Sponaugle R" first="Richard" last="Sponaugle">Richard Sponaugle</name>
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<title level="j">Journal of the American Medical Informatics Association : JAMIA</title>
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<p> This 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.</p>
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<journal-id journal-id-type="nlm-ta">J Am Med Inform Assoc</journal-id>
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<journal-title>Journal of the American Medical Informatics Association : JAMIA</journal-title>
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<issn pub-type="ppub">1067-5027</issn>
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<subj-group subj-group-type="heading">
<subject>The Practice of Informatics</subject>
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<article-title>A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process</article-title>
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<contrib contrib-type="author">
<name>
<surname>Ritondo</surname>
<given-names>Michele</given-names>
</name>
<degrees>PhD</degrees>
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<contrib contrib-type="author">
<name>
<surname>Sponaugle</surname>
<given-names>Richard</given-names>
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<degrees>MS</degrees>
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<aff id="d31e37">Affiliation of the authors: University of Maryland, Baltimore, Maryland.</aff>
<author-notes>
<corresp> Correspondence and reprints: Kip Canfield, PhD, IFSM UMBC, 1000 Hilltop Circle, Baltimore, MD 21250. e-mail: <
<email>canfield@umbc.edu</email>
>.</corresp>
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<pub-date pub-type="ppub">
<season>Sep-Oct</season>
<year>1998</year>
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<volume>5</volume>
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<fpage>432</fpage>
<lpage>440</lpage>
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<date date-type="received">
<day>12</day>
<month>12</month>
<year>1997</year>
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<date date-type="accepted">
<day>30</day>
<month>4</month>
<year>1998</year>
</date>
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<permissions>
<copyright-statement>Copyright © 1998, American Medical Informatics Association</copyright-statement>
<copyright-year>1998</copyright-year>
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<abstract>
<p> This 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.</p>
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<notes>
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<fn>
<p>This work was supported by contract 223-95-3003 from the Food and Drug Administration to the University of Maryland, Baltimore School of Pharmacy and the Department of Information Systems.</p>
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</notes>
</front>
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