1. Editor-in-Chief’s Commentary: DIA, TIRS, and ICH

   • Stephen P. Spielberg

   Commentary 30 December 2014 Pages: 297 - 298

2. The Quality of Reporting Harms-Related Data in Clinical Trials of Adjuvant Trastuzumab in Early-Stage Breast Cancer Treatment

   • Ali Mahinbakht
   • Sayeh M. Lavasani
   • Micheal Guirguis

   Safety 30 December 2014 Pages: 299 - 304

3. Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements

   • Amie C. O’Donoghue
   • Helen W. Sullivan
   • Kevin R. Betts

   Safety 30 December 2014 Pages: 305 - 307

4. Investigation of the Safety Profiles of Japanese Clinical Trials

   • Kazuhiro Kanmuri
   • Mamoru Narukawa

   Safety 30 December 2014 Pages: 308 - 315

5. A Practical Guide to Data Monitoring Committees in Adaptive Trials

   • Matilde Sanchez-Kam
   • Paul Gallo
   • Thomas Laage

   Biostatistics 30 December 2014 Pages: 316 - 326

6. A Novel Design for Decision Rules Based on Statistical Testing Strategies of Binary Endpoints in a Definitive Go/No-Go Single-Treatment Clinical Study

   • Ming Zhou
   • Larry Z. Shen

   Biostatistics 30 December 2014 Pages: 327 - 335

7. Assessing the Quality of Database Search Strategies Utilized by Meta-analyses That Evaluate Infectious Disease Drug Therapy

   • Jacob L. Marler
   • Kiana Y. Curry
   • Katie J. Suda

   Biostatistics 30 December 2014 Pages: 336 - 340

8. Understanding the Role and Evidence Expectations of Health Technology Assessment and Coverage/Payer Bodies: What Are They Looking for, and How and Why Does This Differ From What Regulators Require?

   • Chris Henshall
   • Lloyd Sansom
   • Sean Tunis

   Policy 30 December 2014 Pages: 341 - 346

9. The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views

   • Michael W. Jamieson
   • Frances J. Richmond

   Policy 30 December 2014 Pages: 347 - 356

10. ICH: Strengths, Weaknesses, and Future Tasks

    • Sebastian Specht
    • Ingrid Klingmann

    Regulatory Science 30 December 2014 Pages: 357 - 361

11. Comparison of Drug Approvals in Europe Versus the United States

    • Robert W. Makuch
    • Ruizhi Shi

    Regulatory Science 30 December 2014 Pages: 362 - 366

12. Labeling Standards for Biosimilar Products

    • Gregory C. Davis
    • Gretchen M. Bowker

    Regulatory Science 30 December 2014 Pages: 367 - 370

13. Transaction Cost Analysis of the New Drug Application Process: A Case Study of a Multinational Pharmaceutical Company in Japan

    • Shota Hamada
    • Akiko Shibata
    • Koji Kawakami

    Global Health 30 December 2014 Pages: 371 - 377

14. Utilization of Recently Established Drug Information Centers Located in the Public Hospitals of Addis Ababa, Ethiopia: An Assessment

    • Fantawork Samuel
    • Helen Dawit
    • Ayenew Ashenef

    Global Health 30 December 2014 Pages: 378 - 385

15. Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India

    • Kalaiselvan Vivekanandan
    • Jai Prakash
    • Gyanendra Nath Singh

    Global Health 30 December 2014 Pages: 386 - 392

16. A Comparison of the Pharmacokinetics and Drug Safety Among East Asian Populations

    • Masayo Oishi
    • Shintaro Hiro
    • Norisuke Kawai

    Global Health 30 December 2014 Pages: 393 - 403