Why “Therapeutic Innovation and Regulatory Science” Stephen P. Spielberg Editorial 31 December 2017 Pages: 8 - 8
ICH Culture: Its Maintenance and Development Hironobu SaitoMasafumi YokotaTatsuo Kurokawa Policy: Commentary 31 December 2017 Pages: 9 - 10
Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century? Bert P. van LeeuwenChristine PrendergastBarbara Dawson Policy: Commentary 31 December 2017 Pages: 11 - 15
Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGE Kirk W. KerrMarta E. Wosinska Policy: Original Research 31 December 2017 Pages: 16 - 23
FDA’s Expedited Programs and Their Impact on the Availability of New Therapies Nehar DamleShilvi ShahRahul Bhambri Policy: Analytical Report 31 December 2017 Pages: 24 - 28
Culture and Process Change as a Priority for Patient Engagement in Medicines Development Marc BoutinLode DewulfIfy Sargeant Policy: Analytical Report Open access 31 December 2017 Pages: 29 - 38
Analysis of the Utilization Status of Essential Medicines in Beijing’s Community Health Institutions Fang ZhangYu YangShu Chuen Li Global Perspectives: Original Research 31 December 2017 Pages: 39 - 44
Patient Evaluation of Medication Package Leaflets in Al Kharj City, Saudi Arabia Sinaa AlaqeelNahed Al Obaidi Global Perspectives: Original Research 31 December 2017 Pages: 45 - 50
The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States Hideyuki KondoToshiyuki HataNoriatsu Kono Global Perspectives: Commentary 31 December 2017 Pages: 51 - 54
An Update on the Registration of Biosimilars in Malaysia Yvonne Siew Khoon KhooTien Yew TangAzizah Ab Ghani Global Perspectives: Original Research 31 December 2017 Pages: 55 - 59
Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs Weili HePaul GalloMin Lin Statistics: Analytical Report 31 December 2017 Pages: 60 - 68
Current Practices in Choosing Estimands and Sensitivity Analyses in Clinical Trials: Results of the ICH E9 Survey C. FletcherS. TsuchiyaICH E9(R1) Working Group Statistics: Original Research 31 December 2017 Pages: 69 - 76
DIA’s Adaptive Design Scientific Working Group (ADSWG): Best Practices Case Studies for “Less Well-understood” Adaptive Designs Eva MillerPaul GalloYannis Jemiai Statistics: Review 31 December 2017 Pages: 77 - 88
Adjustment for Propensity Score in Nonrandomized Clinical Studies: Comparison of Sivelestat Versus Conventional Therapy for Acute Lung Injury in Acute Respiratory Distress Syndrome Satoru FukimbaraKouji NiibeTakuhiro Yamaguchi Clinical Trials: Original Research 31 December 2017 Pages: 89 - 99
Methodological Extensions of Phase 2 Trial Designs Based on Program-Level Considerations: Further Development of a Case Study in Neuropathic Pain James BologneseJaydeep BhattacharyyaNitin Patel Clinical Trials: Original Research 31 December 2017 Pages: 100 - 110
Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010–2015: Implications for Designing a Regulatory Shortcut to New Drug Application Kyu Chan KwonChulung Lee Regulatory Science: Original Research 31 December 2017 Pages: 111 - 117
Developing a Practical Method for Validation of Computerized Systems Integrated With Smart and/or Wearable Devices for Regulatory Compliance of Clinical Trials Yumi WakabayashiHitoshi MatsuiKeiichi Yamamoto Product Development and Innovation: Original Research 31 December 2017 Pages: 118 - 124
Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape Marina LengsavathAnne Dal PraSusana Goncalves Product Safety: Review 31 December 2017 Pages: 125 - 131
