A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process
Identifieur interne : 000176 ( Pmc/Corpus ); précédent : 000175; suivant : 000177A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process
Auteurs : Kip Canfield ; Michele Ritondo ; Richard SponaugleSource :
- Journal of the American Medical Informatics Association : JAMIA [ 1067-5027 ] ; 1998.
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.
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PubMed: 9760391
PubMed Central: 61324
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PMC:61324Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Case Study of the Evolving Software Architecture for the FDA Generic
Drug Application Process</title>
<author><name sortKey="Canfield, Kip" sort="Canfield, Kip" uniqKey="Canfield K" first="Kip" last="Canfield">Kip Canfield</name>
</author>
<author><name sortKey="Ritondo, Michele" sort="Ritondo, Michele" uniqKey="Ritondo M" first="Michele" last="Ritondo">Michele Ritondo</name>
</author>
<author><name sortKey="Sponaugle, Richard" sort="Sponaugle, Richard" uniqKey="Sponaugle R" first="Richard" last="Sponaugle">Richard Sponaugle</name>
</author>
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<date when="1998">1998</date>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Case Study of the Evolving Software Architecture for the FDA Generic
Drug Application Process</title>
<author><name sortKey="Canfield, Kip" sort="Canfield, Kip" uniqKey="Canfield K" first="Kip" last="Canfield">Kip Canfield</name>
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<author><name sortKey="Ritondo, Michele" sort="Ritondo, Michele" uniqKey="Ritondo M" first="Michele" last="Ritondo">Michele Ritondo</name>
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<author><name sortKey="Sponaugle, Richard" sort="Sponaugle, Richard" uniqKey="Sponaugle R" first="Richard" last="Sponaugle">Richard Sponaugle</name>
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<series><title level="j">Journal of the American Medical Informatics Association : JAMIA</title>
<idno type="ISSN">1067-5027</idno>
<idno type="eISSN">1527-974X</idno>
<imprint><date when="1998">1998</date>
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<front><div type="abstract" xml:lang="en"><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>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Am Med Inform Assoc</journal-id>
<journal-id journal-id-type="publisher-id">jamia</journal-id>
<journal-title-group><journal-title>Journal of the American Medical Informatics Association : JAMIA</journal-title>
</journal-title-group>
<issn pub-type="ppub">1067-5027</issn>
<issn pub-type="epub">1527-974X</issn>
<publisher><publisher-name>American Medical Informatics Association</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">9760391</article-id>
<article-id pub-id-type="pmc">61324</article-id>
<article-id pub-id-type="publisher-id">0050432</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>The Practice of Informatics</subject>
</subj-group>
</article-categories>
<title-group><article-title>A Case Study of the Evolving Software Architecture for the FDA Generic
Drug Application Process</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Canfield</surname>
<given-names>Kip</given-names>
</name>
<degrees>PhD</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Ritondo</surname>
<given-names>Michele</given-names>
</name>
<degrees>PhD</degrees>
</contrib>
<contrib contrib-type="author"><name><surname>Sponaugle</surname>
<given-names>Richard</given-names>
</name>
<degrees>MS</degrees>
</contrib>
</contrib-group>
<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>
</author-notes>
<pub-date pub-type="ppub"><season>Sep-Oct</season>
<year>1998</year>
</pub-date>
<volume>5</volume>
<issue>5</issue>
<fpage>432</fpage>
<lpage>440</lpage>
<history><date date-type="received"><day>12</day>
<month>12</month>
<year>1997</year>
</date>
<date date-type="accepted"><day>30</day>
<month>4</month>
<year>1998</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 1998, American Medical Informatics Association</copyright-statement>
<copyright-year>1998</copyright-year>
</permissions>
<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>
</abstract>
</article-meta>
<notes><fn-group><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>
</fn>
</fn-group>
</notes>
</front>
</pmc>
</record>
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