1. Editor’s Commentary: A New Category of Articles— Regulatory Commentaries

   • J. Rick Turner

   Commentary 30 December 2012 Pages: 517 - 518

2. Mathematical Derivation of Therapeutic Index Based on hERG IC₅₀ Taking Into Account Fraction Unbound in Plasma and Clinical C_max

   • Ryan M. Fryer

   Letter to the Editor Open access 30 December 2012 Pages: 519 - 520

3. Developing Standardized Data: Connecting the Silos

   • Charles K. Cooper
   • ShaAvhrée Buckman-Garner
   • Susan McCune

   Regulatory Commentaries 30 December 2012 Pages: 521 - 522

4. Join FDA/PhUSE Working Groups to Help Harness the Power of Computational Science

   • Lilliam A. Rosario
   • Timothy J. Kropp
   • Charles K. Cooper

   Regulatory Commentaries 30 December 2012 Pages: 523 - 524

5. Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members

   • Josephine Mary Glover
   • Richard Kay

   Regulatory Science 30 December 2012 Pages: 525 - 531

6. Regulation of Herbal Dietary Supplements: Is There a Better Way?

   • Annet Zakaryan
   • Irwin G. Martin

   Herbal Medicine 30 December 2012 Pages: 532 - 544

7. Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices

   • Markus Hartmann
   • Florence Hartmann-Vareilles

   Clinical Trials 30 December 2012 Pages: 545 - 554

8. An Exploratory Evaluation Framework for e-Clinical Data Management Performance

   • HyunJu Lee
   • Sangwon Lee

   Clinical Trials 30 December 2012 Pages: 555 - 564

9. Potential Factors Influencing Regional Differences and Similarities in Multiregional Clinical Trials

   • Masahiko Ohishi

   Clinical Trials 30 December 2012 Pages: 565 - 572

10. Evaluating the Impact of Patient Recruitment and Retention Practices

    • Mary Jo Lamberti
    • Adam Mathias
    • Ken Getz

    Clinical Trials 30 December 2012 Pages: 573 - 580

11. Quality Standards for Antiretrovirals in Indian Pharmacopoeia

    • Kalaiselvan Vivekanandan
    • Hemant Sharma
    • Gyanendra Nath Singh

    Drug Information 30 December 2012 Pages: 581 - 586

12. Indicator-Based Assessment on Antimalarial Drug Availability and Utilization Among Selected Public Health Facilities in Southwest Ethiopia

    • Alemayehu Tadesse Tessema
    • Amene Tesfaye Ayane
    • Nasir Tajure Wabe

    Drug Information 30 December 2012 Pages: 587 - 592

13. Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research

    • Vadim Tantsyura
    • Imogene Grimes
    • Deborah Viola

    Drug Information 30 December 2012 Pages: 593 - 599

14. Linguistic Validation of the French Canadian Work Productivity and Activity Impairment Questionnaire–General Health Version

    • Mary Gawlicki
    • Shawn McKown
    • Eric Bullington

    Global Topics 30 December 2012 Pages: 600 - 606

15. Drug Shortages After the Eastern Japan Earthquake: Experiences in a Tertiary Referral Center

    • Jinichi Mori
    • Kenichi Hasui
    • Masahiro Kami

    Global Topics 30 December 2012 Pages: 607 - 610

16. Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients

    • Daniel Capaldi
    • Kathy Ackley
    • Fran Wincott

    Quality 30 December 2012 Pages: 611 - 626

17. Corrigendum: Improvement of the Drug Allergy Alert for Nonprescription NSAIDs

    • R.W. Soller
    • C. Shaheen
    • J. Lightwood

    Corrigendum 30 December 2012 Pages: 627 - 627