Editor-in-Chief’s Commentary: DIA, TIRS, and ICH Stephen P. Spielberg Commentary 30 December 2014 Pages: 297 - 298
The Quality of Reporting Harms-Related Data in Clinical Trials of Adjuvant Trastuzumab in Early-Stage Breast Cancer Treatment Ali MahinbakhtSayeh M. LavasaniMicheal Guirguis Safety 30 December 2014 Pages: 299 - 304
Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements Amie C. O’DonoghueHelen W. SullivanKevin R. Betts Safety 30 December 2014 Pages: 305 - 307
Investigation of the Safety Profiles of Japanese Clinical Trials Kazuhiro KanmuriMamoru Narukawa Safety 30 December 2014 Pages: 308 - 315
A Practical Guide to Data Monitoring Committees in Adaptive Trials Matilde Sanchez-KamPaul GalloThomas Laage Biostatistics 30 December 2014 Pages: 316 - 326
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 ZhouLarry Z. Shen Biostatistics 30 December 2014 Pages: 327 - 335
Assessing the Quality of Database Search Strategies Utilized by Meta-analyses That Evaluate Infectious Disease Drug Therapy Jacob L. MarlerKiana Y. CurryKatie J. Suda Biostatistics 30 December 2014 Pages: 336 - 340
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 HenshallLloyd SansomSean Tunis Policy 30 December 2014 Pages: 341 - 346
The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views Michael W. JamiesonFrances J. Richmond Policy 30 December 2014 Pages: 347 - 356
ICH: Strengths, Weaknesses, and Future Tasks Sebastian SpechtIngrid Klingmann Regulatory Science 30 December 2014 Pages: 357 - 361
Comparison of Drug Approvals in Europe Versus the United States Robert W. MakuchRuizhi Shi Regulatory Science 30 December 2014 Pages: 362 - 366
Labeling Standards for Biosimilar Products Gregory C. DavisGretchen M. Bowker Regulatory Science 30 December 2014 Pages: 367 - 370
Transaction Cost Analysis of the New Drug Application Process: A Case Study of a Multinational Pharmaceutical Company in Japan Shota HamadaAkiko ShibataKoji Kawakami Global Health 30 December 2014 Pages: 371 - 377
Utilization of Recently Established Drug Information Centers Located in the Public Hospitals of Addis Ababa, Ethiopia: An Assessment Fantawork SamuelHelen DawitAyenew Ashenef Global Health 30 December 2014 Pages: 378 - 385
Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India Kalaiselvan VivekanandanJai PrakashGyanendra Nath Singh Global Health 30 December 2014 Pages: 386 - 392
A Comparison of the Pharmacokinetics and Drug Safety Among East Asian Populations Masayo OishiShintaro HiroNorisuke Kawai Global Health 30 December 2014 Pages: 393 - 403