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Journal of Clinical Pharmacology|January 9, 2025
Are Exposure Recommendations for QT Evaluation Being Fulfilled?Tsubasa Wakabayashi, Mamoru NarukawaClinical Pharmacology and Therapeutics|October 3, 2024
New Drug Development Strategy in Japan: Flexibility in Guideline AdherenceMihoko Kobayashi, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|February 10, 2025
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory StudiesAkira Ito, Mamoru NarukawaYakugaku Zasshi : Journal of the Pharmaceutical Society of Japan|July 5, 2022
[Association between Post-marketing Safety-related Regulatory Actions and Characteristics of New Drugs Approved in Japan between 2005 and 2016]Yuta Watanabe, Mamoru NarukawaOrphanet Journal of Rare Diseases|April 19, 2023
Randomized controlled trial data for successful new drug application for rare diseases in the United StatesYosuke Kubota, Mamoru NarukawaClinical Drug Investigation|December 4, 2018
Effects of Sodium-glucose Cotransporter 2 Inhibitors on Amputation, Bone Fracture, and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus Using an Alternative Measure to the Hazard RatioMasayuki Kaneko, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|July 25, 2022
A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United StatesYuko Hoshino, Mamoru NarukawaInternational Journal of Clinical Pharmacology and Therapeutics|September 15, 2015
Factors affecting intrasubject variability of PK exposure: absolute oral bioavailability and acidic nature of drugsMasahiko Sato, Mamoru NarukawaSpringerplus|July 8, 2016
Characteristics of safety information obtained from postmarketing observational studies for re-examination in JapanTatsuya Watanabe, Mamoru NarukawaThe Annals of Pharmacotherapy|June 18, 2017
Assessment of the Risk of Hospitalization for Heart Failure With Dipeptidyl Peptidase-4 Inhibitors, Saxagliptin, Alogliptin, and Sitagliptin in Patients With Type 2 Diabetes, Using an Alternative Measure to the Hazard RatioMasayuki Kaneko, Mamoru NarukawaPageof 12