1. Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia

   • Jayanthi Boobalan
   • Kyu-Been Sohn
   • Ornamphai Shinawatra

   Analytical Report 09 January 2024 Pages: 223 - 233

   

2. Training New DMC Members: A Call to Action

   • Frank Rockhold
   • Kenneth Mahaffey
   • David DeMets

   Commentary 25 September 2023 Pages: 234 - 235

3. Delivering Digital Health Solutions that Patients Need: A Call to Action

   • Veronica Popa
   • Jan Geissler
   • Nicholas Brooke

   Commentary Open access 11 December 2023 Pages: 236 - 241

4. Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment

   • Amalia Alexe
   • Anju Garg
   • David Lewis

   Review Open access 17 December 2023 Pages: 242 - 257

   

5. Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations

   • Ashwin Mali
   • Vijaykumar Kuvar
   • Saily Bharadwaj

   Review 06 December 2023 Pages: 258 - 272

   

6. An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits

   • Rakhi Kilaru
   • Sonia Amodio
   • Susan Talbot

   Review Open access 26 December 2023 Pages: 273 - 284

   

7. Correction: An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits

   • Rakhi Kilaru
   • Sonia Amodio
   • Susan Talbot

   Correction Open access 20 January 2024 Pages: 285 - 285

8. Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach

   • Nicola Antognini
   • Ronald Portman
   • Deepa H. Chand

   Review Open access 18 December 2023 Pages: 286 - 302

9. The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8

   • Madeleine Whitehead
   • Melissa Suprin
   • Vimi Abdul-Shukkoor

   Original Research Open access 01 December 2023 Pages: 303 - 310

   

10. A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data

    • Zachary Smith
    • Kenneth Getz

    Original Research 01 December 2023 Pages: 311 - 315

    

11. 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 Saito
    • Hidefumi Nakamura
    • Akimasa Yamatani

    Original Research 06 December 2023 Pages: 316 - 335

    

12. Pediatric Market Access: A Qualitative Study

    • Lieke Maas
    • Angelika Joos
    • Mickael Hiligsmann

    Original Research Open access 03 January 2024 Pages: 336 - 346

13. Quantifying Site Burden to Optimize Protocol Performance

    • Maria Florez
    • Zachary Smith
    • Kenneth Getz

    Original Research 08 January 2024 Pages: 347 - 356

14. Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model

    • Takashi Watanabe
    • Kaori Ambe
    • Masahiro Tohkin

    Original Research Open access 22 December 2023 Pages: 357 - 367

    

15. Aggregate IND Safety Reporting for Smaller Companies and Programs

    • Greg Ball
    • Mengchun Li
    • Jay Herson

    Original Research 08 January 2024 Pages: 368 - 379

16. 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. Gendy
    • Naomi Nomura
    • Gideon Blumenthal

    Original Research Open access 05 January 2024 Pages: 380 - 386

    

17. Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval

    • Yoshihiro Oda
    • Mamoru Narukawa

    Original Research 04 January 2024 Pages: 387 - 394