MedDRA Labeling Groupings to Improve Safety Communication in Product Labels Ilona Große-MichaelisScott ProestelWilliam Gregory Commentary Open access 08 August 2022 Pages: 1 - 6
Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide Andrew DeavinSarah AdamCharlie Mortazavi Commentary Open access 02 August 2022 Pages: 7 - 11
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward Sannie Siaw Foong ChongMasaaki KannoRichard Simon R. Binos Original Research Open access 29 September 2022 Pages: 12 - 25
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine Netta BeerSusanne KaaeIngrid Hegger Original Research Open access 09 August 2022 Pages: 26 - 36
Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019 Mei KohamaTakahiro NonakaChieko Ishiguro Original Research 13 August 2022 Pages: 37 - 47
Correction: Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019 Mei KohamaTakahiro NonakaChieko Ishiguro Correction 25 August 2022 Pages: 48 - 48
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups Kenneth GetzZachary SmithMarcy Kravet Original Research 12 August 2022 Pages: 49 - 56
Pharmacometrics: The Already-Present Future of Precision Pharmacology Lorena Cera BandeiraLeonardo PintoCláudia Martins Carneiro Review 18 August 2022 Pages: 57 - 69
Emergence of New Drugs for Intractable Diseases is Associated with an Increase in the Number of Patients Diagnosed Thereafter with Those Intractable Diseases Toshiya OkaMamoru Narukawa Original Research 08 August 2022 Pages: 70 - 78
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency Kassa AyalewYang-Min NingNi A. Khin Original Research Open access 16 August 2022 Pages: 79 - 85
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan Mao OnoKiyotaka Iwasaki Original Research Open access 07 September 2022 Pages: 86 - 99
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action Hervé Le LouëtPeter J. Pitts Commentary 11 August 2022 Pages: 100 - 103
Japanese Regulatory Considerations for Interoperability of Medical Devices Kazuma IshimotoTatsuhiko ArafuneMasuo Kondoh Analytical Report 22 August 2022 Pages: 104 - 108
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation Thomas R. FlemingChristine E. GarnettLynne Yao Original Research Open access 03 September 2022 Pages: 109 - 120
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study Carly ChingMohammad Ahsan FuzailVeronika J. Wirtz Original Research 25 August 2022 Pages: 121 - 131
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application Nancy A. ShermanRobert SilbergleitKevin D. Wolter Original Research Open access 20 August 2022 Pages: 132 - 141
Bayesian Method of Borrowing Study-Level Historical Longitudinal Control Data for Mixed-Effects Models with Repeated Measures Hong LiMan JinLi Wang Original Research 31 October 2022 Pages: 142 - 151
Leveraging Patient Preference Information in Medical Device Clinical Trial Design Liliana Rincon-GonzalezWendy K. D. SeligBarry Liden Analytical Report Open access 27 August 2022 Pages: 152 - 159
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals Duane SchulthessHarry P. BowenJoe Hammang Original Research Open access 03 September 2022 Pages: 160 - 169
Correction: The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals Duane SchulthessHarry P. BowenJoe Hammang Correction Open access 16 September 2022 Pages: 170 - 171
