The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power Rong TangWei-Chen ChenYu Zhao Original Research Open access 05 February 2024 Pages: 465 - 472
Decentralized Clinical Trials in the Development of Drugs and Biological Products Ryan RobinsonLeonard Sacks Commentary Open access 02 February 2024
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa Armel ZemsiLorraine Jinette Guedem NekameUmberto D’Alessandro Analytical Report Open access 29 January 2024 Pages: 395 - 403
Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method Sai DharmarajanZhong YuanRam Tiwari Analytical Report 24 January 2024 Pages: 415 - 422
Correction: An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits Rakhi KilaruSonia AmodioSusan Talbot Correction Open access 20 January 2024 Pages: 285 - 285
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia Jayanthi BoobalanKyu-Been SohnOrnamphai Shinawatra Analytical Report 09 January 2024 Pages: 223 - 233
Aggregate IND Safety Reporting for Smaller Companies and Programs Greg BallMengchun LiJay Herson Original Research 08 January 2024 Pages: 368 - 379
Quantifying Site Burden to Optimize Protocol Performance Maria FlorezZachary SmithKenneth Getz Original Research 08 January 2024 Pages: 347 - 356
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies Joseph M. GendyNaomi NomuraGideon Blumenthal Original Research Open access 05 January 2024 Pages: 380 - 386
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval Yoshihiro OdaMamoru Narukawa Original Research 04 January 2024 Pages: 387 - 394
Pediatric Market Access: A Qualitative Study Lieke MaasAngelika JoosMickael Hiligsmann Original Research Open access 03 January 2024 Pages: 336 - 346
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits Rakhi KilaruSonia AmodioSusan Talbot Review Open access 26 December 2023 Pages: 273 - 284
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model Takashi WatanabeKaori AmbeMasahiro Tohkin Original Research Open access 22 December 2023 Pages: 357 - 367
Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach Nicola AntogniniRonald PortmanDeepa H. Chand Review Open access 18 December 2023 Pages: 286 - 302
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment Amalia AlexeAnju GargDavid Lewis Review Open access 17 December 2023 Pages: 242 - 257
Delivering Digital Health Solutions that Patients Need: A Call to Action Veronica PopaJan GeisslerNicholas Brooke Commentary Open access 11 December 2023 Pages: 236 - 241
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study Jumpei SaitoHidefumi NakamuraAkimasa Yamatani Original Research 06 December 2023 Pages: 316 - 335
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations Ashwin MaliVijaykumar KuvarSaily Bharadwaj Review 06 December 2023 Pages: 258 - 272
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data Zachary SmithKenneth Getz Original Research 01 December 2023 Pages: 311 - 315
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8 Madeleine WhiteheadMelissa SuprinVimi Abdul-Shukkoor Original Research Open access 01 December 2023 Pages: 303 - 310
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions Pei LiSu WangYuwen Chen Review Open access 23 November 2023 Pages: 34 - 41
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device Peter BakerTamika CatheyJared R. Auclair Analytical Report Open access 22 November 2023 Pages: 11 - 15
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space Sheena DupuyLaura OpincarEvelyn R. Hermes-DeSantis Original Research Open access 10 November 2023 Pages: 200 - 213
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial? Terry KatzMaryrose PetrizzoMunish Mehra Letter to the Editor 07 November 2023 Pages: 18 - 20
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019 Atasi PoddarMiranda RaggioJohn Concato Original Research Open access 05 November 2023 Pages: 214 - 221
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study Dawn EdwardsN. BestA. Fowler Analytical Report Open access 01 November 2023 Pages: 1 - 10
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in Japan Tomoaki HasegawaSono SawadaYoshiaki Uyama Original Research Open access 29 October 2023 Pages: 192 - 199
Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century Ensei Miura Original Research 27 October 2023 Pages: 184 - 191
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study Sampada GandhiBenjamin TaylorKevin Wolter Original Research 27 October 2023 Pages: 166 - 174
An Evaluation of the Swissmedic Regulatory Framework for New Active Substances Magda BujarSimon Andreas Dalla Torre di SanguinettoNeil McAuslane Original Research Open access 26 October 2023 Pages: 153 - 165
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals Muhammed Y. IdrisWilliam E. FitzsimmonsPriscilla Pemu Original Research 23 October 2023 Pages: 175 - 183
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations Marina GhadanianEllen Schafheutle Original Research Open access 20 October 2023 Pages: 79 - 113
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches Eric P. Brass Letter to the Editor 18 October 2023 Pages: 16 - 17
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil Flávia Nathiely Silveira FachelRoselena Silvestri SchuhUrsula Matte Review 10 October 2023 Pages: 21 - 33
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts Shuai WangRobert FrederichJames P. Mancuso Original Research Open access 07 October 2023 Pages: 114 - 126
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan Akira ItoMamoru Narukawa Original Research 03 October 2023 Pages: 136 - 142
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics Zachary SmithEmily BottoKenneth Getz Original Research 29 September 2023 Pages: 143 - 152
Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials Ran DuanKaiyi ChenYongming Qu Original Research 26 September 2023 Pages: 127 - 135
Training New DMC Members: A Call to Action Frank RockholdKenneth MahaffeyDavid DeMets Commentary 25 September 2023 Pages: 234 - 235
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review Neil BertelsenLode DewulfNicholas Brooke Original Research Open access 24 September 2023 Pages: 63 - 78
Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China Ziling XiangHui JiangHang Zheng Original Research 18 September 2023 Pages: 53 - 62
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data Mengjia YuSheng ZhongLi Wang Original Research 15 September 2023 Pages: 42 - 52
Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications Urimara ArgottiLada LeyensVirginia Cozzi Original Research Open access 08 September 2023 Pages: 1287 - 1297
Planning Benefit-Risk Assessments Using Visualizations Michael W. ColopyLovemore GakavaChen Chen Analytical Report 08 September 2023 Pages: 1123 - 1135
Prioritizing Early Disease Intervention H. Hugo CaicedoJonathan J. DarrowAlex Pentland Commentary 05 September 2023 Pages: 1148 - 1152
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China Feifei PengHang Zheng Original Research 31 August 2023 Pages: 1314 - 1321
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions Pei LiSu WangYuwen Chen Review Open access 25 August 2023 Pages: 1167 - 1179
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement Raymond A. HumlDeborah CollyarJingjing Ye Analytical Report 24 August 2023 Pages: 1136 - 1147
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video Xinruo ZhangKatherine Brind’AmourCynthia J. Girman Original Research Open access 17 August 2023 Pages: 1304 - 1313
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka Manori JayasingheThotawaththage Loshadhi Indunika SrilalShukry Zawahir Original Research 17 August 2023 Pages: 1248 - 1259