Clinical Development and Regulatory Pathways of Monoclonal Antibodies in Japan Hua LiaoZhaoyang Li Review 25 November 2021 Pages: 173 - 183
Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials Reema ShahNil PatelPaul F. Weber Review Open access 09 January 2022 Pages: 184 - 190
Anti-lung Cancer Marine Compounds: A Review Mohammad Reza MiriAfshin ZareAmin Tamadon Review 13 January 2022 Pages: 191 - 205
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals Stephen A. SonsteinLisa Palladino KimBarbara E. Bierer Analytical Report 05 January 2022 Pages: 206 - 211
Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot Ya Grace GaoSamantha RobertsAllison Guy Analytical Report Open access 10 January 2022 Pages: 212 - 219
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation Kenichi NakamuraHitoshi OzawaHaruko Yamamoto Original Research Open access 17 November 2021 Pages: 220 - 229
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response Erika FujiiTakuya TakataMayumi Shikano Original Research Open access 22 November 2021 Pages: 230 - 243
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection Cynthia HuberTim FriedeNorbert Benda Original Research Open access 28 November 2021 Pages: 244 - 254
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection Adrijo ChakrabortyJianjin XuRam Tiwari Original Research 22 January 2022 Pages: 255 - 262
Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis Takuya TakataHajime SasakiMayumi Shikano Original Research Open access 22 November 2021 Pages: 263 - 275
Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA Lerato MoetiMadira LiteduJacques Joubert Original Research 02 December 2021 Pages: 276 - 290
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology Kristine BroglioJayne MarshallPaul Frewer Original Research 06 January 2022 Pages: 291 - 300
Issues on Powder Forms for Oral Solution and Suspension for Pediatric Patients in Japan: A Questionnaire-Based Observational Survey to Pediatric Pharmacists Jumpei SaitoHidefumi NakamuraAkimasa Yamatani Original Research 28 January 2022 Pages: 301 - 312
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors Daniel Tobias MichaeliHasan Basri YagmurThomas Michaeli Original Research Open access 11 January 2022 Pages: 313 - 322
The Occurrence of Encephalitis Due to Immune Checkpoint Inhibitors: A Pharmacovigilance Study Yugo ChisakiHiroki HataYoshitaka Yano Original Research 10 January 2022 Pages: 323 - 332
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance Zachary SmithRalf BilkeKenneth Getz Original Research 30 January 2022 Pages: 333 - 345
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA Zhong WangSharon K. AhluwaliaMarkham C. Luke Original Research 03 February 2022 Pages: 346 - 357
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis Satoru ItoMamoru Narukawa Original Research 05 February 2022 Pages: 358 - 365
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences? Kevin KleinPieter StolkIsabelle Stöckert Original Research 07 February 2022 Pages: 366 - 377