1. Editor-in-Chief’s Commentary: SAGE Publishes the Drug Information Journal

   • J. Rick Turner

   Commentary 31 December 2012 Pages: 5 - 6

2. The Ditchley Transparency Manifesto

   • Ragnar Lofstedt
   • Frederic Bouder

   Commentary 31 December 2012 Pages: 7 - 7

3. An In-Process Scaling Model: A Potential Framework for Data Monitoring Committees and Clinical Trial Quality Improvement

   • Alan Smith
   • Jonathan Seltzer

   Clinical Trials 31 December 2012 Pages: 8 - 12

4. Flexible Phase I Study Designs: Expediting Early Clinical Drug Development

   • David Underwood

   Clinical Trials 31 December 2012 Pages: 13 - 18

5. Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research

   • Ihn Sook Jeong
   • Dong-Hee Kim
   • Ji Hong Shon

   Clinical Trials 31 December 2012 Pages: 19 - 26

6. Patient Nonadherence in Clinical Trials: Could There Be a Link to Postmarketing Patient Safety?

   • Dorothy L. Smith

   Clinical Trials 31 December 2012 Pages: 27 - 34

7. Improving Time to Pharmaceutical Approval: An Analysis of the Prescription Drug User Fee Act Process

   • Andrea C. Masciale
   • Patricia L. DeSantis
   • Jay P. Siegel

   Clinical Trials 31 December 2012 Pages: 35 - 42

8. Experiences With the Approval of Clinical Trials in Germany: Results of a Survey of Research-Based Pharmaceutical Companies

   • Thorsten Ruppert
   • Boris Mirko Pfeiffer

   Clinical Trials 31 December 2012 Pages: 43 - 56

9. An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States

   • Reem Al-Essa
   • Sam Salek
   • Stuart Walker

   Regulatory Affairs 31 December 2012 Pages: 57 - 64

10. Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences

    • Reem Al-Essa
    • Sam Salek
    • Stuart Walker

    Regulatory Affairs 31 December 2012 Pages: 65 - 72

11. Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review

    • Sam Salek
    • Andrea Mallia-Milanes
    • Stuart Walker

    Regulatory Affairs 31 December 2012 Pages: 73 - 83

12. CPI™ Certification as Predictor of Clinical Investigators’ Regulatory Compliance

    • David M. Vulcano

    Regulatory Affairs 31 December 2012 Pages: 84 - 87

13. Providing Medical Information for Orphan Drugs

    • Sean Turbeville
    • David A. Wells
    • Carl S. Hornfeldt

    Drug Information 31 December 2012 Pages: 88 - 93

14. The Correction of Product Information in Drug References and Medical Textbooks

    • Ching Lum PharmD
    • Soo Mi Ahn PharmD

    Drug Information 31 December 2012 Pages: 94 - 98

15. The Association Between Leukotriene-Modifying Agents and Spontaneously Reported Suicide

    • Glen T. Schumock
    • Robert D. Gibbons
    • Robert J. Valuck

    Drug Information 31 December 2012 Pages: 99 - 106

16. The Role of Pharmaceutical Medical Information in Promotional Review: Three Benchmarking Surveys

    • Lisa Bonk
    • Madhuri Kothari
    • Ellen Yang

    Drug Information 31 December 2012 Pages: 107 - 114

17. Text Analytics for Surveillance (TAS): An Interactive Environment for Safety Literature Review

    • Camilla Christensson
    • Geoffrey Gipson
    • James Weatherall

    Drug Information 31 December 2012 Pages: 115 - 123

18. The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process

    • Andreas Suchanek
    • Herwig Ostermann

    Student Papers 31 December 2012 Pages: 124 - 139

19. Cobert’s Manual of Drug Safety and Pharmacovigilance

    • Edward Tabor

    Book Reviews 31 December 2012 Pages: 140 - 140