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FDA/PhUSE CSS Conference Proceedings: FDA/PhUSE US Computational Science Symposium 2014
March 17-18, 2014, Silver Spring, Maryland, 30 papers
FDA/PhUSE CSS 2012   FDA/PhUSE CSS 2013   FDA/PhUSE CSS 2014   FDA/PhUSE CSS 2015   FDA/PhUSE CSS 2016   FDA/PhUSE CSS 2017  

[Original source: http://www.phuse.eu/css-presentations-2014]

FDA/PhUSE US Computational Science Symposium 2014: Best Papers and honorable mentions

Reduce Programming Time with Reusable Templates
  Cathal Gallagher, Dootsonic; Alistair Dootson, Dootsonic (Winning Industry Poster in Posters)
Demographic Representation in Aggregated Diabetes Clinical Trials
  Shondelle Wilson-Frederick, HHS, Office of Minority Health; Helena Sviglin, FDA Centre for Drug Evaluation and Research; Lilliam Rosario, FDA Centre for Drug Evaluation and Research; ShaAvhree Buckman-Garner, FDA Centre for Drug Evaluation and Research; Jonca Bull, FDA, Office of the Commissioner, Office of Minority Health (Winning FDA Poster in Posters)

Posters

Posters
tweet!  PhUSE CSS White Paper on Analyses and Displays Associated with Outliers/Shifts from Normal to Abnormal
  Wei Wang, Eli Lilly & Company; Mary Nilsson, Eli Lilly & Company
Keywords: poster presentation poster design poster template
Pages: 1 Size: 1951 Kb 
tweet!  The PhUSE Therapeutic Area Wiki Page
  Angelo Tinazzi, Cytel Inc.; Sascha Ahrweiler, UCB BioSciences; Oliver Wirtz, UCB BioSciences; Christian Mueller, F.Hoffman-La Roche
Pages: 1 Size: 950 Kb 
tweet!  PhUSE CSS White Paper on Analyses and Displays Associated with Central Tendancy
  Mary Nilsson, Eli Lilly & Co.; Wei Wang, Eli Lilly & Co.; Qi Jiang, Eli Lilly & Co.
Keywords: poster presentation poster design poster template
Pages: 1 Size: 1664 Kb 
tweet!  SEND Architecture Facilitates Harmonization and Aggregation of Data from Different Organizations/LIM
  Frederic Mura, PDS Preclinical Data Systems Inc.; Richard Buchanan, PDS Preclinical Data Systems Inc.; Michael Wasko, PDS Preclinical Data Systems Inc.
Pages: 1 Size: 87 Kb 
tweet!  Comparison of FDA and OpenCDISC SEND Validator Rules
  Laura Kaufman, PDS Preclinical Data Systems Inc.; Maro Shuster, PDS Preclinical Data Systems Inc.; Richard Buchanan, PDS Preclinical Data Systems Inc.; Frederic Mura, PDS Preclinical Data Systems Inc.
Pages: 1 Size: 516 Kb 
tweet!  Legacy Data Meets CDISC - Experiences from Working with Evolving Standards in eSubmission Projects
  Beate Hientzsch, Accovion; Dirk Spruck, Accovion
Pages: 1 Size: 1043 Kb 
tweet!  PhUSE CSS White Paper on Analyses and Displays Associated with Demographics, Dispositions and Medical History
  Simin Baygani, Eli Lilly & Company
Pages: 1 Size: 1237 Kb 
tweet!  Selecting a CRO for Creating and Integrating SEND Datasets from Multiple Organizations
  Gerald Randolph, PDS Inc.; William Houser, Bristol-Myers Squibb, on behalf of Interorganizational SEND Project Team for the Non-Clinical Road-map and Impacts on Implementation Working Group
Pages: 1 Size: 171 Kb 
tweet!  Recommendations on Use of the Clinical SDRG Model for Nonclinical Data Submission
  Laura Kaufman, PDS Inc.; Susan DeHaven, PDS Inc. & Non-Clinical SDRG Working Group
Pages: 1 Size: 4610 Kb 
tweet!  The Analysis Data Review Guide ADRG
  Susan Kenny, Amgen
Pages: 1 Size: 537 Kb 
tweet!  Application of a Quality System to the Generation and Submission of SEND Files
  Carolyn McGary, Bristol-Myers Squibb; William Houser, Bristol-Myers Squibb
Pages: 1 Size: 14485 Kb 
tweet!  SEND Datasets from Studies Conducted at Multiple Organizations: An Update Based on Current Practices
  Jeffrey Foy, Celgene; Troy Simmons, Zoetis; Debra Oetzman, Covance; Kathryn Brown, Sanofi; William Houser, Bristol-Myers Squibb; Lynda Sands, Glaxo Smith Kline; Peggy Zorn, INDS Inc.; Gerald Randolph, Roche; Isaac Hatzell, Janssen
Pages: 1 Size: 1528 Kb 
Winning Industry Poster
tweet!  Reduce Programming Time with Reusable Templates
  Cathal Gallagher, Dootsonic; Alistair Dootson, Dootsonic
Pages: 1 Size: 1228 Kb 
tweet!  PhUSE CSS White Paper on Analyses and Displays Associated to Pharmacokinetics - with a Focus on Clinical Trials
  Francois Vandenhende, UCB BioSciences; Ingrid Burton, UCB BioSciences; Sascha Ahrweiler, UCB BioSciences
Pages: 1 Size: 536 Kb 
tweet!  Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies
  Jennifer Feldman, Instem; Megan Bausman, Covance; Paul Brown, CDER, FDA; Lauren Mihalcik, CDER, FDA; Nancy Everds, Amgen; Judith Henck, Eli Lilly & Co; Dan Potenta, Novartis; John Sims, Pfizer; Joyce Zandee INDs Inc.
Pages: 1 Size: 1481 Kb 
tweet!  PhUSE Computational Science Symposium (CSS) White Paper on Analyses and Displays Associated with Adverse Events
  Sheryl McCoy, Amgen.; Qi Jiang, Amgen; Mary Nilsson, Eli Lilly & Co.
Pages: 11 Size: 261 Kb 
tweet!  Legacy Data from Topical Corticosteroid Clinical Trials: Issues in SDTM Conversion
  Aijun Qiu, CDER, FDA; Hon-Sum Ko, CDER, FDA
Pages: 1 Size: 125 Kb 
tweet!  Industry Standard Good Programming Practices Guidance V1.0 Now Available
  Beate Hientzsch, Accovion; Art Collins, Biogen Idec; Mark Foxwell, PRA, on behalf of the GPP Steering Board
Pages: 1 Size: 508 Kb 
tweet!  PhUSE CSS White Paper on Analyses Associated with Hepatotoxicity
  Terry Walsh, Astellas Pharma Global Development
Pages: 15 Size: 252 Kb 
tweet!  Representing CDISC Foundation Standards in RDF
  Scott Bahlavooni, Biogen Idec; Frederik Malfait, IMOS; Geoff Low, Medidata
Pages: 1 Size: 860 Kb 
tweet!  Specs in Analysis Out - The Automatic Way
  Endri Endri, EE Analysis - ICRC Weyer GmbH
Pages: 1 Size: 2410 Kb 
tweet!  Lessons Learned from SEND Implementations at the FDA and Sponsor Companies
  Shree Nath, PointCross Life Sciences; Fristi Johnson, PointCross Life Sciences
Pages: 1 Size: 69 Kb 
tweet!  Use of a Bioinformatics Tool, MASE (Molecular Analysis of Side Effects), Generates the Hypothesis of an Association between FGFR2 and Bone Fractures
  Peter Schotland, FDA/CDER/OTS/OCP/IO; Keith K. Burkhart, FDA/CDER/OTS/OCP/IO; Darrell Abernethy, FDA/CDER/OTS/OCP/IO
Pages: 1 Size: 1939 Kb 
tweet!  Time to Spectrum Culture Conversion as a Trial Endpoint: Re-Use and Cross Study Analysis of Standardized Tuberculosis Trial Data
  Eileen Navarro, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Bobbie Witczak, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Joy Li, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Lilliam Rosario, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Xianbin Li, Office of Biostatistics, Office of Translational Science, CDER, FDA, HHS
Pages: 1 Size: 1097 Kb 
tweet!  Interactive Data Visualization of Clinical Trials Data with D3.js
  John Ho, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Joy Li, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Eileen Navarro, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Mary Doi, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Timothy Kropp, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Lilliam Rosario, Office of Computational Science, Office of Translational Science, CDER, FDA, HHS; Paul Schuette, Office of Biostatistics, Office of Translational Science, CDER, FDA, HHS
Pages: 1 Size: 286 Kb 
tweet!  Using Semantic Web Technologies to Manage FDA Electronic Submissions Policy Information
  Mitra Rocca, CDER Office of Translational Sciences; Syed Haider, CDER Office of Translational Sciences; Armando Oliva, CDER Office of Computational Science
Pages: 1 Size: 596 Kb 
Winning FDA Poster
tweet!  Demographic Representation in Aggregated Diabetes Clinical Trials
  Shondelle Wilson-Frederick, HHS, Office of Minority Health; Helena Sviglin, FDA Centre for Drug Evaluation and Research; Lilliam Rosario, FDA Centre for Drug Evaluation and Research; ShaAvhree Buckman-Garner, FDA Centre for Drug Evaluation and Research; Jonca Bull, FDA, Office of the Commissioner, Office of Minority Health
Pages: 1 Size: 3393 Kb 
tweet!  Modernizing the Review Process through Technology - Janus Clinical Trials Repository
  Bobbie Witczak, FDA/CDER/OTS/Office of Computational Science ; Mary Doi, FDA/CDER/OTS/Office of Computational Science
Pages: 1 Size: 2399 Kb 
tweet!  How to Design a Custom SDTM Domain for Nonclinical Data Overview
  Gitte Frausing, Novo Nordisk; Debra Oetzman, Covance; Kathy Powers, Pfizer; Lynda Sands, Glaxo Smith Kline; Donna Danduone, Instem; Robert Dorsam, FDA, CDER; Sara Obbers, Janssen Research & Development; Anisa Scott, JMP Life Sciences, SAS Institute
Pages: 1 Size: 1283 Kb 
tweet!  The PPi Risk Explorer, It's Development and Application in Assessing the Interaction of Drugs to Treat Osteoporosis and Proton Pump Inhibitions (PPIs) Use in the Risk of Osteoporosis Related Adverse E
  Zhongjun Luo, Jing Yang, Zheng Zuo, Marcea Whitaker, Nancy Xu, Lan Huang, Ram Tiwari, Weida Tong, Lilliam Rosario, Susan McCune & ShaAvhree Buckman-Garner, FDA & Charles Cooper, Becton, Dickinson & Co.
Pages: 1 Size: 569 Kb 
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