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
Training New DMC Members: A Call to Action Frank RockholdKenneth MahaffeyDavid DeMets Commentary 25 September 2023 Pages: 234 - 235
Delivering Digital Health Solutions that Patients Need: A Call to Action Veronica PopaJan GeisslerNicholas Brooke Commentary Open access 11 December 2023 Pages: 236 - 241
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment Amalia AlexeAnju GargDavid Lewis Review Open access 17 December 2023 Pages: 242 - 257
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations Ashwin MaliVijaykumar KuvarSaily Bharadwaj Review 06 December 2023 Pages: 258 - 272
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits Rakhi KilaruSonia AmodioSusan Talbot Review Open access 26 December 2023 Pages: 273 - 284
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
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
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
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
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
Pediatric Market Access: A Qualitative Study Lieke MaasAngelika JoosMickael Hiligsmann Original Research Open access 03 January 2024 Pages: 336 - 346
Quantifying Site Burden to Optimize Protocol Performance Maria FlorezZachary SmithKenneth Getz Original Research 08 January 2024 Pages: 347 - 356
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
Aggregate IND Safety Reporting for Smaller Companies and Programs Greg BallMengchun LiJay Herson Original Research 08 January 2024 Pages: 368 - 379
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