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Clinical Pharmacology and Therapeutics|July 12, 2025
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma CompaniesMihoko Kobayashi, Mamoru NarukawaClinical Pharmacology and Therapeutics|December 9, 2024
Background Factors Contributing to Safety Warning Discordance in the Initial Labeling of New Drugs in Japan, the United States, and the European UnionKoichi Fukuda, Mamoru NarukawaBiological & Pharmaceutical Bulletin|July 24, 2024
Characteristics of Clinical Trials for the US Food and Drug Administration Accelerated Approval and Subsequent Confirmatory Trials: Implications for Drug Approval in JapanHiroaki Mamiya, Mamoru NarukawaInternational Journal of Clinical Oncology|August 10, 2023
Oncology drug lag in Japan: has it improved over the last decade?Yoshifumi Tachibana, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|September 27, 2024
Paediatric Drug Development in Japan: Current Status and Future ChallengesRieko Inagaki, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|March 18, 2026
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA ApprovalsKaku Saito, Mamoru NarukawaJournal of Clinical Pharmacology|April 14, 2022
Combinations of Drug Candidate Properties Affecting Development Success and Discontinuation for 5 Diseases: Lymphoma, Non-Small Cell Lung Cancer, Arthritis, Depression, and Alzheimer DiseaseShingo Yamaguchi, Mamoru NarukawaCancer Control : Journal of the Moffitt Cancer Center|February 7, 2023
Anti-Tumor Efficacy of Anti-PD-1/PD-L1 Antibodies in Combination With Other Anticancer Drugs in Solid Tumors: A Systematic Review and Meta-AnalysisTakashi Inoue, Mamoru NarukawaPharmacoepidemiology and Drug Safety|February 9, 2021
A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United StatesYuko Hoshino, Mamoru NarukawaPharmacoepidemiology and Drug Safety|January 13, 2025
A Descriptive Comparative Analysis of Safety Concerns Outlaid in the Risk Management Plans of the European Union and JapanTeruyuki Honda, Mamoru NarukawaPageof 12