Articles

1. Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

   • Sai Dharmarajan
   • Zhong Yuan
   • Ram Tiwari

   Analytical Report 24 January 2024 Pages: 415 - 422

   

2. 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

3. 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

   

4. Aggregate IND Safety Reporting for Smaller Companies and Programs

   • Greg Ball
   • Mengchun Li
   • Jay Herson

   Original Research 08 January 2024 Pages: 368 - 379

5. Quantifying Site Burden to Optimize Protocol Performance

   • Maria Florez
   • Zachary Smith
   • Kenneth Getz

   Original Research 08 January 2024 Pages: 347 - 356

6. 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

   

7. 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

   

8. Pediatric Market Access: A Qualitative Study

   • Lieke Maas
   • Angelika Joos
   • Mickael Hiligsmann

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

9. 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

   

10. 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

    

11. 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

12. 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

    

13. 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

14. 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

    

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

    • Ashwin Mali
    • Vijaykumar Kuvar
    • Saily Bharadwaj

    Review 06 December 2023 Pages: 258 - 272

    

16. 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

    

17. 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

    

18. Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions

    • Pei Li
    • Su Wang
    • Yuwen Chen

    Review Open access 23 November 2023 Pages: 34 - 41

19. Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device

    • Peter Baker
    • Tamika Cathey
    • Jared R. Auclair

    Analytical Report Open access 22 November 2023 Pages: 11 - 15

20. An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space

    • Sheena Dupuy
    • Laura Opincar
    • Evelyn R. Hermes-DeSantis

    Original Research Open access 10 November 2023 Pages: 200 - 213

    

21. Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?

    • Terry Katz
    • Maryrose Petrizzo
    • Munish Mehra

    Letter to the Editor 07 November 2023 Pages: 18 - 20

22. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019

    • Atasi Poddar
    • Miranda Raggio
    • John Concato

    Original Research Open access 05 November 2023 Pages: 214 - 221

    

23. Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study

    • Dawn Edwards
    • N. Best
    • A. Fowler

    Analytical Report Open access 01 November 2023 Pages: 1 - 10

    

24. 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 Hasegawa
    • Sono Sawada
    • Yoshiaki Uyama

    Original Research Open access 29 October 2023 Pages: 192 - 199

    

25. 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

    

26. Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study

    • Sampada Gandhi
    • Benjamin Taylor
    • Kevin Wolter

    Original Research 27 October 2023 Pages: 166 - 174

    

27. An Evaluation of the Swissmedic Regulatory Framework for New Active Substances

    • Magda Bujar
    • Simon Andreas Dalla Torre di Sanguinetto
    • Neil McAuslane

    Original Research Open access 26 October 2023 Pages: 153 - 165

    

28. Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals

    • Muhammed Y. Idris
    • William E. Fitzsimmons
    • Priscilla Pemu

    Original Research 23 October 2023 Pages: 175 - 183

29. 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 Ghadanian
    • Ellen Schafheutle

    Original Research Open access 20 October 2023 Pages: 79 - 113

    

30. 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

31. Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil

    • Flávia Nathiely Silveira Fachel
    • Roselena Silvestri Schuh
    • Ursula Matte

    Review 10 October 2023 Pages: 21 - 33

    

32. Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts

    • Shuai Wang
    • Robert Frederich
    • James P. Mancuso

    Original Research Open access 07 October 2023 Pages: 114 - 126

    

33. 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 Ito
    • Mamoru Narukawa

    Original Research 03 October 2023 Pages: 136 - 142

    

34. New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics

    • Zachary Smith
    • Emily Botto
    • Kenneth Getz

    Original Research 29 September 2023 Pages: 143 - 152

35. Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials

    • Ran Duan
    • Kaiyi Chen
    • Yongming Qu

    Original Research 26 September 2023 Pages: 127 - 135

    

36. Training New DMC Members: A Call to Action

    • Frank Rockhold
    • Kenneth Mahaffey
    • David DeMets

    Commentary 25 September 2023 Pages: 234 - 235

37. Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review

    • Neil Bertelsen
    • Lode Dewulf
    • Nicholas Brooke

    Original Research Open access 24 September 2023 Pages: 63 - 78

    

38. Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China

    • Ziling Xiang
    • Hui Jiang
    • Hang Zheng

    Original Research 18 September 2023 Pages: 53 - 62

    

39. Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data

    • Mengjia Yu
    • Sheng Zhong
    • Li Wang

    Original Research 15 September 2023 Pages: 42 - 52

    

40. Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications

    • Urimara Argotti
    • Lada Leyens
    • Virginia Cozzi

    Original Research Open access 08 September 2023 Pages: 1287 - 1297

    

41. Planning Benefit-Risk Assessments Using Visualizations

    • Michael W. Colopy
    • Lovemore Gakava
    • Chen Chen

    Analytical Report 08 September 2023 Pages: 1123 - 1135

    

42. Prioritizing Early Disease Intervention

    • H. Hugo Caicedo
    • Jonathan J. Darrow
    • Alex Pentland

    Commentary 05 September 2023 Pages: 1148 - 1152

43. Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China

    • Feifei Peng
    • Hang Zheng

    Original Research 31 August 2023 Pages: 1314 - 1321

    

44. Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions

    • Pei Li
    • Su Wang
    • Yuwen Chen

    Review Open access 25 August 2023 Pages: 1167 - 1179

45. Aiding the Adoption of Master Protocols by Optimizing Patient Engagement

    • Raymond A. Huml
    • Deborah Collyar
    • Jingjing Ye

    Analytical Report 24 August 2023 Pages: 1136 - 1147

46. Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video

    • Xinruo Zhang
    • Katherine Brind’Amour
    • Cynthia J. Girman

    Original Research Open access 17 August 2023 Pages: 1304 - 1313

    

47. Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka

    • Manori Jayasinghe
    • Thotawaththage Loshadhi Indunika Srilal
    • Shukry Zawahir

    Original Research 17 August 2023 Pages: 1248 - 1259

    

48. Direct-to-Consumer Genetic Testing: A Comprehensive Review

    • Sharon Jiang
    • Lawrence Liberti
    • David Lebo

    Review 17 August 2023 Pages: 1190 - 1198

49. Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan

    • Yoko Aoi
    • Yuta Kato
    • Yoshiaki Uyama

    Original Research 16 August 2023 Pages: 1298 - 1303

    

50. Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

    • Francesco Scaglione
    • Paola Minghetti
    • Huub Schellekens

    Review Open access 14 August 2023 Pages: 1153 - 1166