1. Clinical Development and Regulatory Pathways of Monoclonal Antibodies in Japan

   • Hua Liao
   • Zhaoyang Li

   Review 25 November 2021 Pages: 173 - 183

   

2. Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials

   • Reema Shah
   • Nil Patel
   • Paul F. Weber

   Review Open access 09 January 2022 Pages: 184 - 190

   

3. Anti-lung Cancer Marine Compounds: A Review

   • Mohammad Reza Miri
   • Afshin Zare
   • Amin Tamadon

   Review 13 January 2022 Pages: 191 - 205

   

4. Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

   • Stephen A. Sonstein
   • Lisa Palladino Kim
   • Barbara E. Bierer

   Analytical Report 05 January 2022 Pages: 206 - 211

   

5. Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot

   • Ya Grace Gao
   • Samantha Roberts
   • Allison Guy

   Analytical Report Open access 10 January 2022 Pages: 212 - 219

   

6. Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

   • Kenichi Nakamura
   • Hitoshi Ozawa
   • Haruko Yamamoto

   Original Research Open access 17 November 2021 Pages: 220 - 229

   

7. Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response

   • Erika Fujii
   • Takuya Takata
   • Mayumi Shikano

   Original Research Open access 22 November 2021 Pages: 230 - 243

   

8. Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection

   • Cynthia Huber
   • Tim Friede
   • Norbert Benda

   Original Research Open access 28 November 2021 Pages: 244 - 254

   

9. Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection

   • Adrijo Chakraborty
   • Jianjin Xu
   • Ram Tiwari

   Original Research 22 January 2022 Pages: 255 - 262

   

10. Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis

    • Takuya Takata
    • Hajime Sasaki
    • Mayumi Shikano

    Original Research Open access 22 November 2021 Pages: 263 - 275

    

11. Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA

    • Lerato Moeti
    • Madira Litedu
    • Jacques Joubert

    Original Research 02 December 2021 Pages: 276 - 290

    

12. Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology

    • Kristine Broglio
    • Jayne Marshall
    • Paul Frewer

    Original Research 06 January 2022 Pages: 291 - 300

    

13. Issues on Powder Forms for Oral Solution and Suspension for Pediatric Patients in Japan: A Questionnaire-Based Observational Survey to Pediatric Pharmacists

    • Jumpei Saito
    • Hidefumi Nakamura
    • Akimasa Yamatani

    Original Research 28 January 2022 Pages: 301 - 312

14. Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors

    • Daniel Tobias Michaeli
    • Hasan Basri Yagmur
    • Thomas Michaeli

    Original Research Open access 11 January 2022 Pages: 313 - 322

    

15. The Occurrence of Encephalitis Due to Immune Checkpoint Inhibitors: A Pharmacovigilance Study

    • Yugo Chisaki
    • Hiroki Hata
    • Yoshitaka Yano

    Original Research 10 January 2022 Pages: 323 - 332

    

16. Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance

    • Zachary Smith
    • Ralf Bilke
    • Kenneth Getz

    Original Research 30 January 2022 Pages: 333 - 345

    

17. Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

    • Zhong Wang
    • Sharon K. Ahluwalia
    • Markham C. Luke

    Original Research 03 February 2022 Pages: 346 - 357

    

18. Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis

    • Satoru Ito
    • Mamoru Narukawa

    Original Research 05 February 2022 Pages: 358 - 365

    

19. Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?

    • Kevin Klein
    • Pieter Stolk
    • Isabelle Stöckert

    Original Research 07 February 2022 Pages: 366 - 377