1. Editor’s Commentary: Regulatory Science and the Science of Safety

   • J. Rick Turner

   Commentary 01 May 2011 Pages: 221 - 227

2. Associate Editor’s Commentary: Innovation Nation

   • Peter J. Pitts

   Commentary 01 May 2011 Pages: 229 - 231

3. Why ABPM Should Be Mandatory in All Trials of Blood Pressure-Lowering Drugs

   • Eoin O’Brien

   Commentary 01 May 2011 Pages: 233 - 239

4. Focus on the Cardiac Safety Research Consortium

   • Mitchell Krucoff

   Focus On 01 May 2011 Pages: 241 - 244

5. FDAAA Basic Results Reporting: First Experience and Challenges

   • Hans-Theo Forst
   • Robert Paarlberg
   • Elizabeth Roberts

   Regulatory Affairs 01 May 2011 Pages: 245 - 252

6. Substantial Evidence: When is a Single Trial Sufficient for Approval and Promotion?

   • David Coutant
   • David Riggs
   • Elizabeth Van Sant Hoffman

   Regulatory Affairs 01 May 2011 Pages: 253 - 263

7. Measuring the Incidence, Causes, and Repercussions of Protocol Amendments

   • Kenneth A. Getz
   • Rachael Zuckerman
   • Kenneth I. Kaitin

   Regulatory Affairs 01 May 2011 Pages: 265 - 275

8. The Physicians’ Labeling Rule: An Evaluation of Compliance

   • Amy L. Ebel
   • Thomas G. Cantu
   • Maryann Ziemba

   Regulatory Affairs 01 May 2011 Pages: 277 - 290

9. A Meta-analysis to Assess the FDA DAVP’s TLOVR Algorithm in HIV Submissions

   • Fraser Smith
   • Thomas Hammerstrom
   • Mohammad Huque

   Statistics 01 May 2011 Pages: 291 - 300

10. Statistical Analysis for Long-term Stability Studies with Multiple Storage Conditions

    • Edwin R. van den Heuvel
    • Osama Almalik
    • Edward I. Warner

    Statistics 01 May 2011 Pages: 301 - 314

11. A Two-Stage Adaptive Design in Phase 2 Clinical Trials for Acute Treatment of Migraine

    • Xiaoyin Frank Fan
    • Chris A. Assaid
    • Tony W. H. Ho

    Statistics 01 May 2011 Pages: 315 - 330

12. Conditional Type I Error Rate for Superiority Test Conditioned on Establishment of Noninferiority in Clinical Trials

    • Jiacheng Yuan
    • Tiejun Tong
    • Tie-Hua Ng

    Statistics 01 May 2011 Pages: 331 - 336

13. Call Handling in the Pharmaceutical Industry: A Benchmarking Survey

    • Catherine Nojiri
    • Chandni Patel

    Medical Communications 01 May 2011 Pages: 337 - 343

14. Time-Cost Optimization of Complex Clinical Trials

    • Douglas Gregory

    Clinical Trials 01 May 2011 Pages: 345 - 356

15. Assessing a Drug’s Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study

    • Lawrence Z. Satin
    • Todd A. Durham
    • J. Rick Turner

    Clinical Trials 01 May 2011 Pages: 357 - 375

16. Factors Influencing Investigative Site Willingness and Ability to Participate in Clinical Trials

    • Mary Jo Lamberti
    • Rachael Zuckerman
    • Kenneth A. Getz

    Clinical Trials 01 May 2011 Pages: 377 - 390

17. Proceedings of the DIA Workshop on Multiregional Clinical Trials, October 26–27, 2010

    • Ekopimo Okon Ibia
    • Bruce Binkowitz

    Proceedings 01 May 2011 Pages: 391 - 403