Our Annual Meeting Is Fast Approaching: Chicago Here We Come! J. Rick Turner Editorial 30 December 2017 Pages: 272 - 273
Introduction to the Special Section: Phase I Clinical Trials Richard O. Day Special Section — Phase 1 Clinical Trials: Introduction 30 December 2017 Pages: 274 - 275
Safety in FIH Trials: A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost” Howard E. GreenbergMattheus Thijs van IerselWilliam B. Smith Special Section — Phase 1 Clinical Trials: Meeting Report 30 December 2017 Pages: 276 - 284
Special Populations in Clinical Pharmacology Studies: Evolving Challenges William B. SmithHarry Alcorn Jr. Special Section — Phase 1 Clinical Trials: Meeting Report 30 December 2017 Pages: 285 - 287
Structured Risk Assessment for First-in-Human Studies Mattheus Thijs van IerselHoward E. GreenbergMary L. Westrick Special Section — Phase 1 Clinical Trials: Commentary 30 December 2017 Pages: 288 - 297
Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session Gary L. SteinmanWilliam B. SmithHoward E. Greenberg Special Section — Phase 1 Clinical Trials: Meeting Report 30 December 2017 Pages: 298 - 302
Phase 1: An Upcoming Series of White Papers for Successful Early Clinical Development Stacie J. Bell Special Section — Phase 1 Clinical Trials: Commentary 30 December 2017 Pages: 303 - 303
Describing the Endpoint: Consistency Across Protocols, Study Reports, Postings, and Publications Yeshi Mikyas Clinical Trials: Analytical Report 30 December 2017 Pages: 304 - 306
Advances in Clinical Research in Ecuador Thelvia I. RamosKarina Alexandra CastroNelson Santiago Vispo Global Perspectives: Review 30 December 2017 Pages: 307 - 313
Empirical Study on Job Satisfaction of Clinical Research Associates in China Hang ZhengJing WuHe Sun Global Perspectives: Original Research 30 December 2017 Pages: 314 - 321
Using Off-Label Communications to Responsibly Advance the Public Health Peter J. Pitts Policy: Commentary 30 December 2017 Pages: 322 - 326
Reducing Call Volume at Medical Information Centers by Switching to a Web-Based Self-Service Facility—What to Consider? Providing Customers With Digital Medical Information on the Internet Marie-Luise Helmich Product Development and Innovation: Original Research 30 December 2017 Pages: 327 - 331
Risk of Acute Asthma Attacks Associated With Nonsteroidal Anti-inflammatory Drugs: A Self-Controlled Case Series Yoshinori TakeuchiTakashi AndoYoshiaki Uyama Product Safety: Original Research 30 December 2017 Pages: 332 - 341
The Company Core Data Sheet in Light of XML-Authoring and IDMP Master Data Implementation Stefan Hock Product Safety: Review 30 December 2017 Pages: 342 - 351
The Impact of Innovation: How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework Michael DohertyNancy Bradish MyersAnne Petruska McNickle Regulatory Science: Commentary 30 December 2017 Pages: 352 - 354
A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products Hideyuki KondoToshiki SugitaNaoyuki Yasuda Regulatory Science: Analytical Report 30 December 2017 Pages: 355 - 359
Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States Dobromir PenkovPaolo TomasiJean Temeck Regulatory Science: Original Article 30 December 2017 Pages: 360 - 371
Development of the Observable Behaviors of Autism Spectrum Disorder Scale Linda S. DealCarla DeMuroSandy Lewis Special Populations: Original Research 30 December 2017 Pages: 372 - 379
Clinically Meaningful Outcomes in Early Alzheimer Disease: A Consortia-Driven Approach to Identifying What Matters to Patients Michael T. RopackiKristin HannesdottirCritical Path Institute’s Coalition Against Major Diseases and Patient-Reported Outcome Consortium Cognition Working Group Special Populations: Original Research 30 December 2017 Pages: 380 - 390
