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FDA/PhUSE CSS Conference Proceedings: FDA/PhUSE US Computational Science Symposium 2015
March 15-17, 2015, Silver Spring, Maryland, 34 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-2015]


tweet!  Adding in Vivo Mammalian Cytogentics Data to SEND and ToxML
  Mohammed Ashfaq, Lhasa Ltd; Gitte Frausing, Data Standards Decisions Aps; David Bower, Leadscope
Pages: 1 Size: 912 Kb 
tweet!  An Analysis of Data De-Identification Practices in Use at Leading Biopharmaceutical Companies
  Dave Handelsman, d-Wise
Pages: 1 Size: 7581 Kb 
tweet!  CSS PhUSE White Paper Update on Analyses and Displays Associated with Outliers or Shifts from Natural to Abnormal
  Wei Wang, Eli Lilly & Company; Mary Nilsson, Eli Lilly & Company
Pages: 2 Size: 825 Kb 
tweet!  Enhancing the Productivity of Analysis and Reporting through Collaborative Innovation
  Stephen Matterson, Pfizer; Chris Fenaughty, Pfizer; Unnat Patel, Pfizer
Pages: 1 Size: 723 Kb 
tweet!  Resampling Methods as Applied to Significance Tests: A Case Study
  Veronica Powelll, Theorem Clinical Research; Carrie Caswell, Theorem Clinical Research
Pages: 1 Size: 6209 Kb 
tweet!  Legacy Data Conversion Issues for Topical Product Studies
  Aijun Qiu, FDA, CDER; Hon-Sum Ko, FDA
Pages: 1 Size: 229 Kb 
tweet!  Adapting to Adaptive
  Angelo Tinazzi, Cytel; Ashish Aggarwal, Cytel; Steve Wong, Cytel
Pages: 1 Size: 368 Kb 
tweet!  SEND (and SDTM) Implementation Guide Web-Based EASY Search Tool
  Bob Friedman, Xybion Corporation; Wenxian Wang, Xybion Corporation; Michael Wasko, PDS Life Sciences
Pages: 1 Size: 1388 Kb 
tweet!  Template to Facilitate Creation Pharmacokinetics Concentrations SEND Datasets (PC Domain)
  William Houser, Bristol-Myers Squibb; Richard Buchanan, PDS Preclinical Data Systems; Christy Kubin, Brian Argo, and other iSEND Team Members
Pages: 1 Size: 175 Kb 
tweet!  SEND Data from Small/Medium Service Providers: How Prepared are they to Supply Data in SEND Format?
  Richard Buchanan, PDS Preclinical Data Systems; William Houser, Bristol-Myers Squibb
Pages: 1 Size: 267 Kb 
tweet!  PhUSE CSS White Paper on Analyses Associated with Hepatotoxcity
  Terry Walsh, Astellas Pharma Global Development
Pages: 16 Size: 236 Kb 
tweet!  Creating CDISC Test Data Sets - A Worthwhile Concept?
  Peter Schaefer, Independent
Pages: 1 Size: 611 Kb 
tweet!  How Can CDISC Help CDRH?
  Kit Howard, CDISC; Carey Smoak, InClin; Rajesh Nair, FDA, CDRH
Pages: 1 Size: 3390 Kb 
tweet!  Beyond Submission: Business Rules in Legacy Data Conversion for better CTR Integration
  Helena Sviglin, FDA; Eileen Navarro, FDA; Bobbie Witczak, FDA; Lilliam Rosario, FDA
Pages: 1 Size: 5016 Kb 
tweet!  Implementing the SDRG: Reflections from the Reviewer Community
  Helena Sviglin, FDA/CDER/OTS/CSC; Eileen Navarro, FDA/CDER/OTS/CSC; Crystal Allard, FDA/CDER/OTS/CSC; Lilliam Rosario, FDA/CDER/OTS/CSC; Jeno Pizarro, IBM, Strategy and Analytics; Ryan Barraco, Booz Allen Hamilton
Pages: 1 Size: 2348 Kb 
tweet!  Outside the Box: Race and Ethnicity in NDA Submissions
  Mina Hohlen, FDA, CDER/OTS/CSC; Eileen Navarro, FDA, CDER/OTS/CSC; Austin Taylor, IBM, Strategy and Analytics; Sergiy Sirichecnko, Pinnacle 21
Pages: 1 Size: 2332 Kb 
tweet!  M*ssing Application Data - Impact on NDA and BLA Reviews
  Eileen Navarro, FDA OCS, OTS; Lilliam Rosario, FDA OCS, OTS; Austin Taylor, IBM; Jeno Pizarro, IBM; Kathryn Matto, IBM; Ryan Barraco, Booz Allen Hamilton; Max Kanevsky, Pinnacle 21
Pages: 1 Size: 4419 Kb 
tweet!  JumpStarting Review: Highlights
  DeYett Law, FDA, OCS, OTS; Patricia Koussis, FDA, OCS, OTS; Crystal Allard, FDA, OCS, OTS; Helena Sviglin, FDA, OCS, OTS; John Ho, FDA, OCS, OTS; Joy Li, FDA, OCS, OTS; Timothy Kropp, FDA, OCS, OTS; Lilliam Rosario, FDA, OCS, OTS; Eileen Navarro, FDA, OCS, OTS; Mary Doi, FDA OND, CDER; Dave Epstein CNI; Ryan Barraco, Booz Allen Hamilton; Austin Taylor, Booz Allen Hamilton; Katherine Matto, IBM; Jeno Pizarro, IBM
Pages: 1 Size: 872 Kb 
tweet!  A Framework for the Adoption of Cloud Services in the Life Science Industry
  Anders Vidstrup, NNIT
Pages: 1 Size: 6512 Kb 
tweet!  Development of Standardized SAS Macros for Demographic Subgroup Participation in NDAs and BLAs Submitted to FDA's Center for Drug Evaluation and Research
  Anne Pariser, FDA; Eileen Navarro Almario, FDA; Lilliam Rosario, FDA
Pages: 1 Size: 2559 Kb 
tweet!  Clinical Site Dataset in eSubmissions to the FDA
  Beate Hientzsch, Accovion; Dirk Spruck, Accovion; Stefanie Sturm, Accovion
Pages: 1 Size: 621 Kb 
tweet!  SDTM can be Customized to Different Types of Nonclinical Data using a Streamlined Decision-Making Process
  Robert Dorsam, FDA; Gitte Frausing, Data Standards Decisions & Roadmap Team Members
Pages: 1 Size: 846 Kb 
tweet!  Dynamic Display of Patient Profiles
  Rebeka Tabbey, Eli Lilly & Company; Wei Wang, Eli Lilly & Company
Pages: 1 Size: 890 Kb 
tweet!  Qualification Process for Standard Scripts Hosted in Open Source Repository
  Dante Di Tommaso, Roche; Hanming Tu, Accenture, & PhUSE CS Working Group development of Standard Scripts for Analysis and Programming
Pages: 1 Size: 638 Kb 
tweet!  Communication: So, We have a New Standard… Now What?
  Wenxian Wang, Xybion Medical Systems; Debra Oetzman, Covance; Troy Smyrnios, Zoetis
Pages: 1 Size: 500 Kb 
tweet!  Standard Scripts for Analysis and Reporting: A Vision within Reach
  Christopher Hurley, MMS Holdings; Frank Senk AstraZeneca
Pages: 1 Size: 1264 Kb 
tweet!  Ensuring USUBJID is Unique for an Individual within an Application
  Monica Mattson, celgene Corportation; Mark Sullivan, Parexel International; Gary Walker, Quintiles
Keywords: poster presentation poster design poster template
Pages: 1 Size: 437 Kb 
tweet!  Operationalizing Global Clinical Trial Disclosures
  Zach Weingarden, MMS Holdings; Joe Archer, MMS Holdings
Pages: 1 Size: 1158 Kb 
tweet!  Review and Analysis of SEND Standardized Data at the FDA
  Kristi Johnson, PointCross Life Sciences; Jillian Sanford, PointCross Life Sciences; Karen Porter, PointCross Life Sciences; Jon Kimball, PointCross Life Sciences; Shree Nath, PointCross Life Sciences
Pages: 1 Size: 960 Kb 
tweet!  Steps and Slides of Implementing Global Standards
  Terek Peterson, Theorem Clinical Research; Karin LaPann, Theorem Clinical Research
Pages: 2 Size: 8472 Kb 
tweet!  AskOCP: Semantically Enhanced Search Applied to Clinical Review Documents
  Eduard Porta, FDA; Martin Moreno, FDA; Ider Peter Lee, FDA
Pages: 1 Size: 3762 Kb 
tweet!  Enabling Integrated Analyses for Hypoglycemic Agents through Standards and Technology
  Tejas Patel, FDA; Helena Sviglin, FDA; Bereket Tesfaldet, FDA; Bobbie Witczak, FDA; Lilliam Rosario, FDA; Eileen Navarro Almario, FDA
Pages: 1 Size: 461 Kb 
tweet!  Text Mining: Expanding into Drug Regulatory Submissions and Surveillance
  Tony Sheaffer, Linguamatics; James Dixon, Linguamatics
Pages: 1 Size: 842 Kb 
tweet!  Template and User Guide for Nonclinical Study data Reviewer's Guide (SDRG)
  Laura Kaufman, PDS Life Sciences; Susan DeHaven, Sanofi & Non-clinical SDRG FDA/PhUSE Working Group
Pages: 1 Size: 204 Kb 
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