Editor-in-Chief’s Commentary: Therapeutic Innovation & Regulatory Science, January 2013 J. Rick Turner Commentary 30 December 2013 Pages: 7 - 7
Collaboration and Convergence: Bringing New Medicines to Global Markets in the 21st Century Alberto Grignolo Commentary 30 December 2013 Pages: 8 - 15
The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan Yasuko AsahinaAyumi TanakaHiroshi Maruyama Commentary 30 December 2013 Pages: 19 - 22
Analysis of the Current Situation of Antibiotics Use in China: A Hospital-Based Perspective Jianhong TaoTiantian ZhangChuanbin Wu Global Perspectives 30 December 2013 Pages: 23 - 31
How FDA Advisory Committee Members Prepare and What Influences Them Todd D. McIntyreMimi PappasJames J. DiBiasi Regulatory Science 30 December 2013 Pages: 32 - 40
FDA Engages Collaborators to Address Nonclinical Data Challenges Timothy J. KroppLilliam A. RosarioJeremy L. Wally Regulatory Science 30 December 2013 Pages: 41 - 45
Formulating an Ethics Agenda for Drug Development, Regulation, and Utilization Wendy L. LipworthIan H. KerridgeRichard O. Day Ethics 30 December 2013 Pages: 46 - 49
Corporate Integrity Agreements: What They Say About Publications, Publication Planning, Transparency, and ICMJE Frank J. Rodino Ethics 30 December 2013 Pages: 50 - 56
Multi-domain Longitudinal Modeling: An Application to the International Index of Erectile Function Andrew G. BushmakinJoseph C. CappelleriVera J. Stecher Statistics 30 December 2013 Pages: 57 - 64
Continuity Correction for the Laster-Johnson-Kotler Noninferiority Asymptotic Statistical Test for 2 Independent Proportions David Sotres-RamosYoni Castillo-TzecFélix Almendra-Arao Statistics 30 December 2013 Pages: 65 - 69
Data Quality Improvement in Clinical Databases Using Statistical Quality Control: Review and Case Study Hassan AssarehMary A. WaterhouseKerrie Mengersen Statistics 30 December 2013 Pages: 70 - 81
Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results Frederick CurroP. Van ThompsonElan Czeisler Clinical Research 30 December 2013 Pages: 82 - 89
Influence of Clinical Research Investigator Fraud on Clinical Trial Participation Purnachandra GarimellaIrwin G. Martin Clinical Research 30 December 2013 Pages: 90 - 94
Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study Lijun ZhangChia-Wen KoRajeshwari Sridhara Clinical Research 30 December 2013 Pages: 95 - 100
Benchmarking the Study Initiation Process Mary Jo LambertiCindy BrothersKen Getz Clinical Trials 30 December 2013 Pages: 101 - 109
Strategies for a Label Claim or Indication in the Context of Robust Point Estimates From Historical Data Jin WangRoseann WhiteLei Peng Drug Information 30 December 2013 Pages: 110 - 115
How Korean and White Americans Evaluate and Use Online Advertising and Non-advertising Sources for Prescription Drug Information Jisu HuhDenise E. DeLormeJunga Kim Drug Information 30 December 2013 Pages: 116 - 124
Consumers Better Understand and Prefer Simplified Written Drug Information: An Evaluation of 2 Novel Formats Versus the Current CMI Julie AkerMelissa BeckKristen Bibeau Drug Information 30 December 2013 Pages: 125 - 132
Exploring Best Practices on Development Regulatory Affairs and Clinical Development Related to Multiregional Clinical Trials (MRCTs) in China, Korea, and Taiwan Tetsuomi Takano Meeting Report 30 December 2013 Pages: 133 - 139