TransCelerate’s Clinical Quality Management System: Issue Management Susan Callery-D’AmicoLeslie M. SamDaniel J. Greenwood Sponsored Special Section by TransCelerate BioPharma: Analytical Report Open access 30 December 2016 Pages: 530 - 535
A Knowledge Management Framework and Approach for Clinical Development Kathy A. SalzanoChrista A. MaurerTeresa Petree Sponsored Special Section by TransCelerate BioPharma: Analytical Report Open access 30 December 2016 Pages: 536 - 545
Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products” Meredith Y. SmithTarek A. HammadF. Reed Johnson Policy: Analytical Report Open access 30 December 2016 Pages: 546 - 553
A Theory on the Relativity of Factors Impacting the Utilization of Medical Information Services From the Pharmaceutical Industry Dominick AlbanoAllison SoloffSudeep Mavila Policy: Analytical Report 30 December 2016 Pages: 554 - 559
Improving Information Processing: The Effect of Label Format Among Current and Potential Over-the-Counter Medication Users Archita H. BhansaliMarc L. FlemingSujit S. Sansgiry Policy: Original Research 30 December 2016 Pages: 560 - 568
Survey of Health Care Practitioners’ Preferences for Medical Information: Collective Insights for Impacting Patient Care Stacey M. FungDannis Y. ChangMatt Suchodolski Policy: Original Research 30 December 2016 Pages: 569 - 576
A Patient Centricity Team Tool to Enable Patient-Focused Drug Development Rebecca AshkenazyRoslyn F. Schneider Product Development and Innovation: Commentary 30 December 2016 Pages: 577 - 580
Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test Study Rebecca DickinsonDavid K. RaynorJan MacDonald Product Development and Innovation: Original Research 30 December 2016 Pages: 581 - 591
The Early Engagement Model in Product Development: Linking “Proof of Concept” to “Proof of Medical Value” Sheikh Usman IqbalTehseen SalimiL. Clark Paramore Product Development and Innovation: Analytical Report 30 December 2016 Pages: 592 - 601
Regulation of New Drug Approval in Taiwan Ya-Ting YangHsiau-Wen HuangMeir-Chyun Tzou Global Perspectives: Review 30 December 2016 Pages: 602 - 608
Attitudes Toward Clinical Trials Among Physicians in China With Different Levels of Experience Hang ZhengLiqing WangHe Sun Global Perspectives: Original Research 30 December 2016 Pages: 609 - 614
The Impact of Adaptive Design on Portfolio Optimization Zoran Antonijevic Statistics: Original Research 30 December 2016 Pages: 615 - 619
Pragmatic Multicriteria Decision Analysis (MCDA) Combined With Advanced Pharmacoepidemiology for Benefit-Risk Assessments of Medicines Adapted to the Real-Life Constraints of Regulators: Development and Case Study Mireille M. GoetghebeurMonika WagnerBilly Amzal Statistics: Original Research 30 December 2016 Pages: 620 - 631
Nonclinical Safety Considerations for the Development of Pediatric-First Drugs: An Industry View G. SchmittJ. RidingsA. Hartmann Special Populations: Review 30 December 2016 Pages: 632 - 638
A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013 Gunter F. EggerGerold T. WhartonPaolo Tomasi Special Populations: Original Research 30 December 2016 Pages: 639 - 647
Responsibilities of Data Monitoring Committees: Consensus Recommendations Barbara E. BiererRebecca LiJanet Wittes Clinical Trials: Analytical Report 30 December 2016 Pages: 648 - 659
Product Development Under FDA’s Animal Rule: Understanding FDA’s Expectations and Potential Implications for Traditional Development Programs Theresa Allio Regulatory Science 30 December 2016 Pages: 660 - 670
