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  • Preparing for a Safety Inspection
    Steve Jolley
    Drug Information Journal

    2011 : 45(06) :
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  • Associate Editor's Commentary: The Danger of Shorting Drug Shortages
    Peter J. Pitts
    Drug Information Journal

    2011 : 45(06) :
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  • Editor's Commentary: A Time for Reflection and Anticipation
    Rick Turner
    Drug Information Journal

    2011 : 45(06) :
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  • Benefit/Risk Estimates in Clinical Trials
    Adil E. Shamoo
    Drug Information Journal

    2011 : 45(05) :
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  • Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program
    Bernard Fine,Lee Kaiser
    Drug Information Journal

    2011 : 45(05) :
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  • Establishing a Complete Drug Information Triad: Academic, Industry, and Hospital Training
    Elizabeth S Miller,Katie J. Suda,Anne M. Hurley,Mina Tadrous,Daniel Gharbawy
    Drug Information Journal

    2011 : 45(05) :
    View Abstract
  • Results of a Survey of PhRMA Member Companies on Practices Associated With Multiregional Clinical Trials
    Nick R Scott,Tonya L Houck,Yoko Tanaka,Bruce Binkowitz,Belinda Field,Ekopimo O. Ibia,Andy Lee,Steven Talerico
    Drug Information Journal

    2011 : 45(05) :
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  • Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and Interpretation
    Soo Ouyang,Paul P. Gallo,Shailendra S. Menjoge,Yoko Tanaka,Bruce Binkowitz,Ekopimo O. Ibia,Gang Li,Hui Quan,Xiaolong Luo,Joshua Chen,Steven Talerico,Kimitoshi Ikeda
    Drug Information Journal

    2011 : 45(05) :
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  • Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials, Part 1: Design Considerations
    Soo Ouyang,Paul P. Gallo,Shailendra S. Menjoge,Yoko Tanaka,Bruce Binkowitz,Ekopimo O. Ibia,Gang Li,Hui Quan,Xiaolong Luo,Joshua Chen,Steven Talerico,Kimitoshi Ikeda
    Drug Information Journal

    2011 : 45(05) :
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  • Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials
    Cynthia J. Girman,Shailendra S. Menjoge,Bruce Binkowitz,Carmen Mak,Anupam Agarwal,Ekopimo O. Ibia,Joshua Chen
    Drug Information Journal

    2011 : 45(05) :
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  • Points to Consider in Defining Region for a Multiregional Clinical Trial: Defining Region Work Stream in PhRMA MRCT Key Issue Team
    Michael A Rabbia,Yoko Tanaka,Bruce Binkowitz,Carmen Mak,Ekopimo O. Ibia,Brent Burger,Joshua Chen,Alex Zolotovitski
    Drug Information Journal

    2011 : 45(05) :
    View Abstract
  • Multiregional Clinical Trials: An Introduction From an Industry Perspective
    Bruce Binkowitz,Ekopimo O. Ibia
    Drug Information Journal

    2011 : 45(05) :
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  • Letters to the Editor
    Norman Stockbridge,Lawrence Z Satin,Eoin O'Brien
    Drug Information Journal

    2011 : 45(05) :
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  • Program Chair Reflects Upon DIA 2011
    Kenneth A. Getz
    Drug Information Journal

    2011 : 45(05) :
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  • DIA 2011 47th Annual Meeting Student Poster Abstracts
    Nicholas H. Schluterman,Anne-Sophie Auroux,Ph. Mohammed Hamdan Al Rubaie,Jie Rena Sun,Jingjing Liu,Kaushal Vinaykumar Sheth,Gabriel Meister,Brian Claggett,Danish Arora,Manasi Datar,Shaunak Praful Kulkarni,Michelle P. Pernice,Andrew W. York,Digvijay Chandrakant Yeola,Joseph Mburu,Nikita Somani
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Expediting Patient Access to New Medicines: A Call to Action, London, January 26-27, 2010
    Peter J. Pitts,Werner Cautreels,Mary Baker
    Drug Information Journal

    2011 : 45(04) :
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  • 5th Annual Cardiovascular Risk Assessment Summit
    Lawrence Z Satin,David E. Gutstein
    Drug Information Journal

    2011 : 45(04) :
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  • Review of the 9th Middle East Regulatory Conference
    Adrian Ball,Mike Stuart Fallows
    Drug Information Journal

    2011 : 45(04) :
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  • Review of International Pharmaceutical Product Registration, 2nd ed.
    Edward Tabor
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Implementation of an Electronic Medical Information Request System for Field-generated Information Inquiries
    Rommel Fernandez,Barbara Schreiner,Edward Bezarro,Helen Yin Yu,Jimmy Thomas Black
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Effect of Direct-to-Consumer Drug Advertising Exposure on Information Search
    Clive Mario Mendonca,David J McCaffrey,Benjamin F. Banahan III,Jonn P. Bently,Yi Yang
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Using Real-time Data to Drive Better Decisions, Faster
    Paula Brown Stafford,Andrew Garrett
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Covariate-adjusted Difference in Proportions From Clinical Trials Using Logistic Regression and Weighted Risk Differences
    Miaomiao Ge,L. Kathryn Durham,R. Daniel Meyer,Wangang Xie,Neal Thomas
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Optimal Sample Size Allocation in a Thorough QTc Study
    Joanne Zhang
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Are Pharmacists a Viable Channel for Education About Clinical Trial Participation?
    Diane Simmons,Jill Chappell,Kenneth A. Getz,Zachary Hallinan,Brian P. Schrock,Dorothy L Smith
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Phase 2 Clinical Development in Treating Chronic Diseases
    Naitee Ting
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database
    Jules T. Mitchel,Yong Joong Kim,Joonhyuk Choi,Glen D Park,Silvana Cappi,David Horn,Morgan Kist,Ralph B. D'Agostino
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Variability in Protocol Design Complexity by Phase and Therapeutic Area
    Kenneth A. Getz,Rafael A. Campo,Kenneth I. Kaitin
    Drug Information Journal

    2011 : 45(04) :
    View Abstract
  • Proceedings of the DIA WOrkshop on Multiregional Clinical Trials, October 26-27, 2010
    Ekopimo O. Ibia,Bruce Binkowitz
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Factors Influencing Investigative SIte Willingness and Ability to Participate in Clinical Trials
    Mary Jo Lamberti,Rachael Zuckerman,Deborah Howe,Lisa E. Shapiro,Kenneth A. Getz
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Time-Cost Optimization of Complex Clinical Trials
    Douglas Gregory
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Call Handling in the Pharmaceutical Industry: A Benchmarking Survey
    Catherine J Nojiri,Chandni Patel
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • A Two-Stage Adaptive Design in Phase 2 Clinical Trials for Acute Treatment of Migraine
    Xiaoyin Frank Fan,Chris Assaid,Yang Joy Ge,Tony W. Ho
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Statistical Analysis for Long-term Stability Studies with Multiple Storage Conditions
    Edwin Van den Heuvel,Osama Almalik,Michiel Nijhuis,Edward I. Warner
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • A Meta-analysis to Asess the FDA DAVP's TLOVR Algorithm in HIV Submissions
    Fraser Smith,Thomas Hammerstrom,Greg Soon,Susan Y Zhou,Baibai Chen,Yabling Mai,Kimberly A. Struble,Mohammad Huque
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • The Physicians' Labeling Rule: An Evaluation of Compliance
    Amy L. Ebel,Thomas G Cantu,Stuart Hobbs,Paula R. Rogenes,Melissa H Beaman,MaryAnn E Ziemba
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Measuring the Incidence, Causes, and Repercussions of Protocol Amendments
    Kenneth A. Getz,Rachael Zuckerman,Anne B. Cropp,Anna L Hindle,Randy Krauss,Kenneth I. Kaitin
    Drug Information Journal

    2011 : 45(03) :
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  • Substantial Evidence: When is a Single Trial Sufficient for Approval and Promotion?
    David Coutant,David Riggs,Elizabeth Van Sant Hoffman
    Drug Information Journal

    2011 : 45(03) :
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  • FDAAA Basic Results Reporting: First Experience and Challenges
    Hans-Theo Forst,Robert Paarlberg,Elizabeth Roberts
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Focus on the Cardia Safety Research Consortium
    Mitchell W. Krucoff
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Associates Editor's Commentary: Innovation Nation
    Peter J. Pitts
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • Editor's Commentary: Regulatory Science and the Science of Safety
    Rick Turner
    Drug Information Journal

    2011 : 45(03) :
    View Abstract
  • 2011 EuroMeeting Student Poster Abstracts
    Blanca Arguello Aguello,Andre David Pestana Andrade,Arna Hrund Arnardottir,Deborah Bacquet,Sabine Marteil,Sandra De Bie,Nancy Gribelin,Juan Francisco Hernandez,Joelle Hoebert,Mohamed Larbi Jelassi,Sandeep Lyall,Fiona Masterson,Wei Pan,Doris Thomas Pereira,Sigrid Piening,Michelle Putzeist,Magali Robin,Aline Chapeyron,Inge Zomerdijk
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Design and Size of Bioequivalence Studies for Inhaled Drugs
    Anders Kallen
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • A Quantitative Approach for Making Gl/No-Go Decisions in Drug Development
    Christy Chuang-Stein,Simon Kirby,Jonathan L. French,Ken Kowalski,Scott Marshall,Mike K. Smith,Paul W. Bycott,Mohan Beltangady
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Some Controversial Issues in Clinical Trials
    Shein-Chung Chow,Lan-Yan Yang,Ying Lu
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Publishing in Academia: Woes of AUthorship, Figures, and Peer Review
    Theodore R. Sadler
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Interpretation and Implementation of Good Publication Practice
    Holly Zoog,Ting Chang
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Little Red Riding Hood and the Big Bad Wolf Revisited
    Linda Fossati Wood
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Topic-based Authoring: A Content Management Paradigm for Accurate, Consistent Regulatory Documents
    Linda Fossati Wood,Michelle Herrera Foster,James M Averback,Peggy Boe,Nancy R. Katz
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Medical Writing: Looking Back, Moving Forward
    MaryAnn Foote
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • The Promise and Progress of DIA 2011
    Kenneth A. Getz
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Editor's Commentary: A Vision for the Journa'ls Continued Growth
    Rick Turner
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
  • Final Thoughts
    Michael R. Hamrell
    Drug Information Journal

    2011 : 45(02) :
    View Abstract
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