Improving women's health through modernization of our bioinformatics infrastructure

Clinical Pharmacology and Therapeutics

Volumn 83, Issue 1, 2008, Pages 192-195

  Oliva, A ^a   Pinnow, E ^a   Levin, R ^a   Uhl, K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOINFORMATICS; FOOD AND DRUG ADMINISTRATION; HEALTH CARE MANAGEMENT; HEALTH SERVICE; PRIORITY JOURNAL; PUBLIC HEALTH; REVIEW; SEX DIFFERENCE; WOMEN'S HEALTH;

CLINICAL TRIALS AS TOPIC; COMPUTATIONAL BIOLOGY; CONSUMER PRODUCT SAFETY; DRUG THERAPY; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMATION DISSEMINATION; MALE; PATIENT SELECTION; PROGRAM DEVELOPMENT; RISK ASSESSMENT; SEX FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOMEN'S HEALTH;

EID: 37549040941     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100437     Document Type: Review

References (10)

1. Lacroix, Z. & Critchlow, T. Bioinformatics: Managing Scientific Data. (Morgan Kaufman Publishers: San Francisco, 2003).
2. US Food and Drug Administration. FDA's Critical Path Initiative 〈http://www.fda.gov/oc/initiatives/criticalpath/〉. Accessed 28 August 2007.
3. Health and Human Services. Health information technology 〈http://www.hhs.gov/healthit/〉. Accessed 28 August 2007.
4. US Food and Drug Administration. Critical path opportunities list and report. Topic 3: Harnessing Bioinformatics, R-15 〈http://www.fda.gov/oc/ initiatives/criticalpath/reports/opp_report.pdf〉. Accessed 28 August 2007 (2006).
5. US General Accounting Office. Drug safety: most drugs withdrawn in recent years had greater health risks for women 〈http://www.gao.gov/new.items/ d01286r.pdf〉. Accessed 28 August 2007.
6. 107th Congress (2001-2002) 1st Session (FY2002). Senate Committee Report (S. Rep. 107-41) 〈http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=107_cong_reports&docid=f:sr041.pdf〉, 146. Accessed 28 August 2007.
7. Clinical Data Interchange Standards Consortium 〈http://www.cdisc. org〉. Accessed 28 August 2007.
8. US Food and Drug Administration. Study Data Specifications, Version 1.3 〈http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf〉. Accessed 28 August 2007.
9. Pinnow, E. Evaluation of NDAs submitted to the FDA in CDISC SDTM format: feasibility of using demographic domain data to track the inclusion of women in trials 〈http://www.cdisc.org/publications/interchange2006/session8/ EllenPinnowCDISC2006Pinnow.pdf〉. Accessed 28 August 2007.
10. Health Level Seven 〈http://www.hl7.org〉. Accessed 28 August 2007.