1. Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview

   • Atul Sharma
   • Shyam Khante
   • Vinod L. Gaikwad

   Review Article 13 January 2020 Pages: 965 - 977

2. Harmonizing Protocol Complexity with Resource Management and Capacity Planning at Clinical Research Sites

   • David J. Morin

   Original Article 13 January 2020 Pages: 978 - 987

   

3. Opinion: Imagine 5P3A Global Health

   • Igor Gonda

   Commentary 14 January 2020 Pages: 988 - 990

   

4. Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation

   • Sandeesha Lunawat
   • Krishnamurthy Bhat

   Review Article 20 January 2020 Pages: 991 - 1000

   

5. Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies

   • Elizabeth Manning
   • Mitch Herndon
   • Stephen L. Yates

   Original Article Open access 21 January 2020 Pages: 1001 - 1009

   

6. Patient Input to Inform the Development of Central Nervous System Outcome Measures in Myotonic Dystrophy

   • Molly White

   Meeting Reports Open access 22 January 2020 Pages: 1010 - 1017

7. Optimal Decision Criteria for the Study Design and Sample Size of a Biomarker-Driven Phase III Trial

   • Akira Takazawa
   • Satoshi Morita

   Original Article 27 January 2020 Pages: 1018 - 1034

   

8. Correction to: Optimal Decision Criteria for the Study Design and Sample Size of a Biomarker‑Driven Phase III Trial

   • Akira Takazawa
   • Satoshi Morita

   Correction 14 April 2020 Pages: 1035 - 1036

9. Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders

   • Pierre Mermet-Bouvier
   • Matthew D. Whalen

   Commentary 27 January 2020 Pages: 1037 - 1046

10. A Comparative Study of the Market Configuration of the Japanese Pharmaceutical Market Using the Gini Coefficient and Herfindahl–Hirschman Index

    • Shoyo Shibata
    • Daigo Fukumoto
    • Koken Ozaki

    Original Research 27 January 2020 Pages: 1047 - 1055

    

11. Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis

    • Iraj Daizadeh

    Original Research 31 January 2020 Pages: 1056 - 1067

    

12. On Innovation

    • Waldo H. Belloso

    Review Articles 05 February 2020 Pages: 1068 - 1075

13. How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

    • Thomas Severin
    • Solange Corriol-Rohou
    • the IQ Pediatric Working Group

    Original Article Open access 06 February 2020 Pages: 1076 - 1084

14. Correction to: How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

    • Thomas Severin
    • Solange Corriol-Rohou
    • the IQ Pediatric Working Group

    Correction 20 April 2020 Pages: 1085 - 1085

15. Patients’ Perspectives of the Pharmaceutical Regulatory and Reimbursement Systems in Istanbul, Turkey

    • Emel Mashaki Ceyhan
    • Stuart Walker
    • Sam Salek

    Original Research 06 February 2020 Pages: 1086 - 1096

    

16. Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan

    • Kentaro Sakamaki
    • Yusuke Morita
    • Satoru Fukimbara

    OriginalPaper 06 February 2020 Pages: 1097 - 1105

    

17. The Competence and Willingness to Consent to Research Among Patients with Heroin Dependence

    • Liyan Zhao
    • Hong Shi
    • Qiang Li

    Original Article 12 February 2020 Pages: 1106 - 1111

18. Modernizing Regulatory Evidence with Trials and Real-World Studies

    • Nancy A. Dreyer
    • Marni Hall
    • Jennifer B. Christian

    Educational Review Open access 18 February 2020 Pages: 1112 - 1115

    

19. WHODrug: A Global, Validated and Updated Dictionary for Medicinal Information

    • Olof Lagerlund
    • Sara Strese
    • Marie Lindquist

    Educational Review Open access 20 February 2020 Pages: 1116 - 1122

    

20. Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018

    • Clinton A. Rogers
    • Jennifer D. Ahearn
    • Michael G. Bartlett

    Original Research 24 February 2020 Pages: 1123 - 1133

21. Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission

    • Yumiko Asami
    • Jean Pan
    • Akira Sato

    Analytical Report 03 March 2020 Pages: 1134 - 1137

22. Expert Commentary: Diverse Meanings of Regulatory “Convergence”

    • Toshiyoshi Tominaga

    Review 03 March 2020 Pages: 1138 - 1140

23. Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View

    • Abhijit A. Parab
    • Prasann Mehta
    • Jesper Kjaer

    Original Research Open access 03 March 2020 Pages: 1141 - 1151

    

24. Pediatric Drug Development in Japan: A Comparison of the Current Situation and Characteristics Between Japan and Europe

    • Eiji Ueyama
    • Masayuki Kaneko
    • Mamoru Narukawa

    Original Research 04 March 2020 Pages: 1152 - 1158

    

25. Establishing Consensus Understanding of the Barriers to Drug Development in Lupus

    • Yaritza Peña
    • Karin Tse
    • Kenneth Getz

    Original Research 06 March 2020 Pages: 1159 - 1165

    

26. Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective

    • Donald G. Jennings
    • Amy Nordo
    • Jesper Kjaer

    Original Articles Open access 11 March 2020 Pages: 1166 - 1174

    

27. Quantitative Safety Monitoring in Clinical Trials: Application of Multiple Statistical Methodologies for Infrequent Events

    • Jiabu Ye
    • Shihua Wen
    • Syed Islam

    Analytical Report 20 March 2020 Pages: 1175 - 1184

    

28. Study Designs in Multi-arm Trials for Breast Cancer: A Systematic Literature Review of Major Journals

    • Shogo Nomura
    • Yu Miyauchi
    • Takashi Sozu

    Original Research 22 March 2020 Pages: 1185 - 1191

    

29. Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan

    • Eiji Kajiwara
    • Haruki Kamizato
    • Mayumi Shikano

    Original Research 24 March 2020 Pages: 1192 - 1198

    

30. Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

    • Andrea Keyter
    • Sam Salek
    • Stuart Walker

    Original Research Open access 25 March 2020 Pages: 1199 - 1207

31. Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer

    • Phil Bonomi
    • Nina Stuccio
    • Wendy Selig

    Original Research 26 March 2020 Pages: 1208 - 1214

    

32. An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

    • Noraisyah Mohd Sani
    • Neil McAuslane
    • Prisha Patel

    Original Research Open access 28 March 2020 Pages: 1215 - 1224

    

33. Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

    • Noraisyah Mohd Sani
    • Neil McAuslane
    • Prisha Patel

    Correction 09 April 2020 Pages: 1225 - 1226

    

34. Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?

    • Björn Koneswarakantha
    • Timothé Ménard
    • Rich Bowling

    Original Research Open access 30 March 2020 Pages: 1227 - 1235

    

35. Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis

    • Weichung J. Shih
    • Chen Yao
    • Tai Xie

    Original Research Open access 16 May 2020 Pages: 1236 - 1255

    

36. Correction to: A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions

    • Chie Iwaishi
    • Kiyotaka Iwasaki

    Correction 10 February 2020 Pages: 1256 - 1257