A Milestone: Therapeutic Innovation & Regulatory Science Has Been Accepted for Inclusion in MEDLINE J. Rick Turner Editorial 30 December 2018 Pages: 265 - 266
Keeping a Focus on Research Ethics Lindsay McNair Special Section — Research Ethics: Editorial 30 December 2018 Pages: 267 - 267
Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials Luke GelinasHolly Fernandez LynchBarbara E. Bierer Special Section — Research Ethics 30 December 2018 Pages: 268 - 274
Adults Lacking Capacity to Give Consent: When Is It Acceptable to Include Them in Research? David G. ForsterDavid A. Borasky Jr Special Section — Research Ethics Open access 30 December 2018 Pages: 275 - 279
Ethical Issues in Research Involving Participants With Opioid Use Disorder Emily AndersonLindsay McNair Special Section — Research Ethics Open access 30 December 2018 Pages: 280 - 284
Improving Expanded Access in the United States: The Role of the Institutional Review Board Kelly McBride FolkersAlison Bateman-House Special Section — Research Ethics 30 December 2018 Pages: 285 - 293
An Alternative to Disproportionality: A Frequency-Based Method for Pharmacovigilance Data Mining Jeremy D. JokinenFabio LievanoMelissa Truffa Biostatistics: Original Research 30 December 2018 Pages: 294 - 299
Sample Size for Biosimilar Trials: In Defense of Synthesis Timothy ClarkSook Jung JoAlan Phillips Biostatistics: Analytical Report 30 December 2018 Pages: 300 - 305
Longitudinal Modeling Approaches to Assess the Association Between Changes in 2 Clinical Outcome Assessments Dawn OdomLori McLeodDavid McSorley Biostatistics: Original Research 30 December 2018 Pages: 306 - 312
A Resource-Based Relative Value for Clinical Research Nurses’ Workload Sangmi LeeIhn Sook Jeong Clinical Trials: Original Research 30 December 2018 Pages: 313 - 320
The Early Preclinical Development Program for Locally Administered Investigational Medicinal Products in Ophthalmology: Preclinical Data Required for Starting a First-in-Human Clinical Trial in Europe—Basic Considerations and 2 Case Studies Annick ToggenburgerRebecca TrönnbergGeorg A. Mathis Global Perspectives: Original Research 30 December 2018 Pages: 321 - 328
Statistical Signal Process in R Language in the Pharmacovigilance Programme of India Aman KumarJitin AhujaVivekanandan Kalaiselvan Global Perspectives: Original Research 30 December 2018 Pages: 329 - 333
Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma Akihiro HirakawaTadaaki NishikawaYasuhiro Fujiwara Global Perspectives: Original Research 30 December 2018 Pages: 334 - 338
Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database Yomei MatsuokaMamoru Narukawa Global Perspectives: Original Research 30 December 2018 Pages: 339 - 347
Evaluation and Characterization of Health Economics and Outcomes Research in SAARC Nations Manthan MehtaRajan Nerurkar Global Perspectives: Original Research 30 December 2018 Pages: 348 - 353
Safety Reporting: It Can Enter the 21st Century—If We Let It Jonathan SeltzerAmit Bhattacharyya Product Safety: Commentary 30 December 2018 Pages: 354 - 361
Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable Nancy A. Dreyer Regulatory Science: Commentary Open access 30 December 2018 Pages: 362 - 368
FDA Expectations for Demonstrating Interchangeability Kamali Chance Regulatory Science: Review 30 December 2018 Pages: 369 - 373
Mobile Health Applications for Caring of Older People: Review and Comparison Victoria Laput Anthony BeraukMuthu Kumar MurugiahLong Chiau Ming Special Populations: Original Research 30 December 2018 Pages: 374 - 382
Mobile Health Applications for Pediatric Care: Review and Comparison Samantha Sangie MorseMuthu Kumar MurugiahLong Chiau Ming Special Populations: Original Research 30 December 2018 Pages: 383 - 391
Erratum to: Implications of CRISPR-based germline engineering for cancer survivors Gregory KatzPeter J. Pitts Erratum 30 December 2018 Pages: 392 - 392
