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Global Forum
Optimal Allocation of Prognostic Factors in Randomized Preclinical Animal StudiesZheng SuDrug Information Journal
Optimal Allocation of Prognostic Factors in Randomized Preclinical Animal Studies Drug Information Journal
Review of: Fundamentals of US Regulatory Affairs, 7th ed. Edward TaborDrug Information Journal
Certification for the Medical Science Liaison: An Idea Whose Time Has come---or NotKenneth L Massey,Jane Chin,Jimmy Thomas BlackDrug Information Journal
Medical Information Services in the Age of Social Media and New Customer ChannelsLesley S. Fierro,Poonam A. Bordoloi,Michelle Clausen,Krupa Paranjpe,Andrew GazoDrug Information Journal
Clinically Important Effects in New Drug DevelopmentSatoshi Hashigaki,Kanae Togo,Takashi Moriya,Keiji ImaiDrug Information Journal
Assessment of Electronic Drug Information Research Availability in Alabama PharmaciesMichael G Kendrach,Bob Schrimsher,Maisha Kelly FreemanDrug Information Journal
Content Analysis of Off-label Drug Use: Reporting Print Media CoverageDavid A. Holdford,Avani D JoshiDrug Information Journal
Failure to Communicate: Medication Guide or Memory ?Louis A Morris,Morris S WhitcupDrug Information Journal
Evaluation of Drug Adverse Event Intake and Reporting in a Medical Information ServiceRobert J. Fuentes,Michael Hoopes,Gregory M Susla,Pamela D AllenDrug Information Journal
Validation of Decision-enabling Tools: Showing That the Model Is UsefulStig J WiklundDrug Information Journal
A Benefit-risk Model to Facilitate DMC-sponsor Communication and Decision MakingAndreas I. SashegyiDrug Information Journal
Letter to the Editor: Selection of the Time Points for a Thorough QTc StudyNorman Stockbridge,Joanne ZhangDrug Information Journal
A Longitudinal Model and Graphic for Benefit-risk Analysis, With Case StudyJonathan D. NortonDrug Information Journal
Platelet Aggregation Quality Control in a Multicenter Phase 2 Clinical TrialJames McRedmondDrug Information Journal
Ten-year Experience of the Evaluation of Ethnic Sensitivity DataChia-Ling HsiaoDrug Information Journal
Letter to the EditorDrug Information Journal
Fewer Drugs, Shorter Lives, Less Prosperity: The Impact of Comparative Effectiveness Research on Health and WealthPeter J. PittsDrug Information Journal
Preparing for a Safety InspectionSteve JolleyDrug Information Journal
Associate Editor's Commentary: The Danger of Shorting Drug ShortagesPeter J. PittsDrug Information Journal
Commentary: The Real-world Convergence of Comparative Effectiveness Research and Risk- Benefit AssessmentJohn DoyleDrug Information Journal
Editor's Commentary: A Time for Reflection and AnticipationRick TurnerDrug Information Journal
Benefit/Risk Estimates in Clinical TrialsAdil E. ShamooDrug Information Journal
Japanese Guideline on Global Clinical Trials: Statistical Implications and Alternative Criteria for Assessing ConsistencyFlorence Le Maulf,Kevin J. CarrollDrug Information Journal
Decision Making for a Companion Diagnostic in an Oncology Clinical Development ProgramBernard Fine,Lee KaiserDrug Information Journal
Establishing a Complete Drug Information Triad: Academic, Industry, and Hospital TrainingElizabeth S Miller,Katie J. Suda,Anne M. Hurley,Mina Tadrous,Daniel GharbawyDrug Information Journal
Reporting of Adverse Drug Reactions by Community Pharmacists: A Qualitative Study in QuebecBenoit RouleauDrug Information Journal
Technical Requirements for Biopharmaceutics Classification System–based Biowaiver in ChinaNing ZhangDrug Information Journal
Results of a Survey of PhRMA Member Companies on Practices Associated With Multiregional Clinical TrialsNick R Scott,Tonya L Houck,Yoko Tanaka,Bruce Binkowitz,Belinda Field,Ekopimo O. Ibia,Andy Lee,Steven TalericoDrug Information Journal
Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and InterpretationSoo P. 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 IkedaDrug Information Journal
Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials, Part 1: Design ConsiderationsSoo P. 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 IkedaDrug Information Journal
Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical TrialsCynthia J. Girman,Shailendra S. Menjoge,Bruce Binkowitz,Carmen Mak,Anupam Agarwal,Ekopimo O. Ibia,Joshua ChenDrug Information Journal
Points to Consider in Defining Region for a Multiregional Clinical Trial: Defining Region Work Stream in PhRMA MRCT Key Issue TeamMichael A Rabbia,Yoko Tanaka,Bruce Binkowitz,Carmen Mak,Ekopimo O. Ibia,Brent Burger,Joshua Chen,Alex ZolotovitskiDrug Information Journal
Multiregional Clinical Trials: An Introduction From an Industry PerspectiveBruce Binkowitz,Ekopimo O. IbiaDrug Information Journal
Letters to the EditorNorman Stockbridge,Lawrence Z Satin,Eoin O'BrienDrug Information Journal
Program Chair Reflects Upon DIA 2011Kenneth A. GetzDrug Information Journal
Editor's Commentary: Letters to the Editor, a New Publishing Partner, and Benefit-risk EstimationRick TurnerDrug Information Journal
DIA 2011 47th Annual Meeting Student Poster AbstractsNicholas H. Schluterman,Anne-Sophie Auroux,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 SomaniDrug Information Journal
Expediting Patient Access to New Medicines: A Call to Action, London, January 26-27, 2010Peter J. Pitts,Werner Cautreels,Mary BakerDrug Information Journal
5th Annual Cardiovascular Risk Assessment Summit Lawrence Z Satin,David E. GutsteinDrug Information Journal
Review of the 9th Middle East Regulatory ConferenceAdrian Ball,Mike Stuart FallowsDrug Information Journal
Review of International Pharmaceutical Product Registration, 2nd ed.Edward TaborDrug Information Journal
Implementation of an Electronic Medical Information Request System for Field-generated Information InquiriesRommel Fernandez,Barbara Schreiner,Edward Bezarro,Helen Yin Yu,Jimmy Thomas BlackDrug Information Journal
Effect of Direct-to-Consumer Drug Advertising Exposure on Information SearchClive Mario Mendonca,David J McCaffrey,Benjamin F. Banahan III,Jonn P. Bently,Yi YangDrug Information Journal
Using Real-time Data to Drive Better Decisions, FasterPaula Brown Stafford,Andrew GarrettDrug Information Journal
Covariate-adjusted Difference in Proportions From Clinical Trials Using Logistic Regression and Weighted Risk DifferencesMiaomiao Ge,L. Kathryn Durham,R. Daniel Meyer,Wangang Xie,Neal ThomasDrug Information Journal
Multiple-stage Sampling Procedure for Lot Release With Consideration of oth Manufacturer's and Consumer's RiskBoguang Zhen,Tie-Hua Ng,Henry HsuDrug Information Journal
Optimal Sample Size Allocation in a Thorough QTc StudyJoanne ZhangDrug Information Journal
Are Pharmacists a Viable Channel for Education About Clinical Trial Participation?Diane Simmons,Jill Chappell,Kenneth A. Getz,Zachary P Hallinan,Brian P. Schrock,Dorothy L SmithDrug Information Journal
Phase 2 Clinical Development in Treating Chronic DiseasesNaitee TingDrug Information Journal
Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial DatabaseJules T. Mitchel,Yong Joong Kim,Joonhyuk Choi,Glen D Park,Silvana Cappi,David Horn,Morgan Kist,Ralph B. D'AgostinoDrug Information Journal
Variability in Protocol Design Complexity by Phase and Therapeutic AreaKenneth A. Getz,Rafael A. Campo,Kenneth I. KaitinDrug Information Journal
Editor's Commentary: Additional Associate Editors, New Submission Category, and Meta-methodologyRick TurnerDrug Information Journal
Proceedings of the DIA WOrkshop on Multiregional Clinical Trials, October 26-27, 2010Ekopimo O. Ibia,Bruce BinkowitzDrug Information Journal
Factors Influencing Investigative SIte Willingness and Ability to Participate in Clinical TrialsMary Jo Lamberti,Rachael Zuckerman,Deborah Howe,Lisa E. Shapiro,Kenneth A. GetzDrug Information Journal
Assessing a Drug's Proarrhythmic Liability: An Oerview of Computer SImulation Modeling, Nonclinical Assays, and the Thorough QT/QTc StudyLawrence Z Satin,Timothy Lee Durham,Rick TurnerDrug Information Journal
Time-Cost Optimization of Complex Clinical TrialsDouglas GregoryDrug Information Journal
Call Handling in the Pharmaceutical Industry: A Benchmarking SurveyCatherine J Nojiri,Chandni PatelDrug Information Journal
Conditional Type I Error Rate for Superiority Test Conditioned on Establishment of Noninferiority in Clinical TrialsJason Yuan,Tiejun Tong,Tie-Hua NgDrug Information Journal
A Two-Stage Adaptive Design in Phase 2 Clinical Trials for Acute Treatment of MigraineXiaoyin Frank Fan,Chris Assaid,Yang Joy Ge,Tony W. HoDrug Information Journal
Statistical Analysis for Long-term Stability Studies with Multiple Storage Conditions Edwin Van den Heuvel,Osama Almalik,Michiel Nijhuis,Edward I. WarnerDrug Information Journal
A Meta-analysis to Asess the FDA DAVP's TLOVR Algorithm in HIV SubmissionsFraser Smith,Thomas Hammerstrom,Greg Soon,Susan Y Zhou,Baibai Chen,Yabling Mai,Kimberly A. Struble,Mohammad HuqueDrug Information Journal
The Physicians' Labeling Rule: An Evaluation of ComplianceAmy L. Ebel,Thomas G Cantu,Stuart Hobbs,Paula R. Rogenes,Melissa H Beaman,MaryAnn E ZiembaDrug Information Journal
Measuring the Incidence, Causes, and Repercussions of Protocol AmendmentsKenneth A. Getz,Rachael Zuckerman,Anne B. Cropp,Anna L Hindle,Randy Krauss,Kenneth I. KaitinDrug Information Journal
Substantial Evidence: When is a Single Trial Sufficient for Approval and Promotion?David Coutant,David Riggs,Elizabeth Van Sant HoffmanDrug Information Journal
FDAAA Basic Results Reporting: First Experience and ChallengesHans-Theo Forst,Robert Paarlberg,Elizabeth RobertsDrug Information Journal
Focus on the Cardia Safety Research ConsortiumMitchell W. KrucoffDrug Information Journal
Why ABPM Should Be Mandatory in All Trials of Blood Pressure - Lowering DrugsEoin O'BrienDrug Information Journal
Associates Editor's Commentary: Innovation NationPeter J. PittsDrug Information Journal
Editor's Commentary: Regulatory Science and the Science of SafetyRick TurnerDrug Information Journal
2011 EuroMeeting Student Poster AbstractsBlanca 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 ZomerdijkDrug Information Journal
Review of Methods and Measures for Using Existing Drug Information Material for Patient InformationPratyush Lohani,Surinder SinghDrug Information Journal
Design and Size of Bioequivalence Studies for Inhaled DrugsAnders KallenDrug Information Journal
A Quantitative Approach for Making Gl/No-Go Decisions in Drug DevelopmentChristy Chuang-Stein,Simon P Kirby,Jonathan L. French,Ken Kowalski,Scott Marshall,Mike K. Smith,Paul W. Bycott,Mohan BeltangadyDrug Information Journal
Assessment of Pharmaceutical Research and Development Productivity with a Novel Net Present Value-based Project DatabaseShintaro Sengoku,Toshihide Yoda,Atsushi SekiDrug Information Journal
Some Controversial Issues in Clinical TrialsShein-Chung Chow,Lan-Yan Yang,Ying LuDrug Information Journal
Requirements for Biosimilars and Interchangeable Biological Drugs in the United States-in Plain LanguageSuzanne M. SensabaughDrug Information Journal
Enhancing the Clinicall Professional's Knowledge of Regulatory DocumentsSherri BowenDrug Information Journal
Publishing in Academia: Woes of AUthorship, Figures, and Peer ReviewTheodore R. SadlerDrug Information Journal
Interpretation and Implementation of Good Publication PracticeHolly Zoog,Ting ChangDrug Information Journal
Little Red Riding Hood and the Big Bad Wolf RevisitedLinda Fossati WoodDrug Information Journal
Topic-based Authoring: A Content Management Paradigm for Accurate, Consistent Regulatory DocumentsLinda Fossati Wood,Michelle Herrera Foster,James M Averback,Peggy Boe,Nancy R. KatzDrug Information Journal
Medical Writing: Looking Back, Moving ForwardMaryAnn FooteDrug Information Journal
The Promise and Progress of DIA 2011Kenneth A. GetzDrug Information Journal
Editor's Commentary: A Vision for the Journa'ls Continued GrowthRick TurnerDrug Information Journal
Final ThoughtsMichael R. HamrellDrug Information Journal
Review of Drug Safety Data: How to Analyze, Summarize, and Interpret to to Determine RiskGerald FaichDrug Information Journal
Review of Drug Safety Data: How to ANalyze, Summarize, and Interpret to Determine RiskAlan M. HochbergDrug Information Journal
Ethical Challenges in Clinical Research at Both Ends of LifePeter Wrobel,Martine Dehlinger-Kremer,Ingrid KlingmannDrug Information Journal
Surveys, Opinion Polls, and Focus Groups: Some Thoughts on How to Report DataMaryAnn FooteDrug Information Journal
Risk Minimization Method Evaluation in OncologyAnne Kehely,Cheryl C. Smith,Andrzej CzarneckiDrug Information Journal
Considerations on Observing Consistent Results of Treatment Effects in Multiregional TrialsJungo Sawa,Akihiro Iwata,Yoshie OnishiDrug Information Journal
A New Mechanism for Tracking Publicly Available Study Volunteer DemographicsRachael Zuckerman,Kenneth A. Getz,Kenneth I. KaitinDrug Information Journal
Quality, Safety, and Efficacy of Herbal Products Through Regulatory HarmonizationSubhash C. Mandal,Mitreyee MandalDrug Information Journal
Black Cohosh for Menopause: Safety and Efficacy Issues and Future PerspectivesKapil K. Soni,Temitopel O. Lawal,Tracie D. Locklear,Gail B MahadyDrug Information Journal
US Dietary Supplement cGMPs: Ingredient Supplier QualificationAndrew ShaoDrug Information Journal
The Legal and Regulatory Framework of Herbal Medicinal Products in the European Union: A Focus on the Traditional Herbal Medicines Category Christelle Anquez-TraxlerDrug Information Journal
Market Profiling: An Approach for Quality Evaluation of Indian Medicinal PlantsPulok K Mukherjee,S. Ponnusankar,P. Venkatesh,Arunava Gantait,Bikas C. PalDrug Information Journal
Global Pharmaceutical Forum (In Chinese)