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Pediatrics International : Official Journal of the Japan Pediatric Society|January 22, 2026
Pediatric off-label use in Japan: Insights from the National Database of Health Insurance ClaimsSaki Aino, Satoko Nanbu, Mamoru Narukawa
Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan|October 5, 2019
[The Current State and Future Prospects of Population Pharmacokinetic Research in Post-marketing Clinical Studies in Japan]Megumi Watanabe-Uchida, Tatsuya Watanabe, Mamoru Narukawa
Journal of Clinical Pharmacology|July 15, 2010
Differences between Japan and the United States in dosages of drugs recently approved in JapanKae Nakashima, Mamoru Narukawa, Yoshiko Kanazu, et al.
Therapeutic Innovation & Regulatory Science|September 21, 2018
Quantitative Assessment of Premium Rates for Clinical Usefulness in New Drug Price Calculation in JapanAkane Takayama, Eriko Kobayashi, Tetsuya Nakamura, et al.
Therapeutic Innovation & Regulatory Science|March 15, 2021
Factors Influencing Regulatory Decision-Making in Signal Management: Analysis Based on the Signals Identified from the FAERSChisato Fukazawa, Yasushi Hinomura, Masayuki Kaneko, et al.
Pharmacoepidemiology and Drug Safety|October 17, 2018
Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDAChisato Fukazawa, Yasushi Hinomura, Masayuki Kaneko, et al.
Orphanet Journal of Rare Diseases|August 25, 2017
Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugsKojiro Maeda, Masayuki Kaneko, Mamoru Narukawa, et al.
Therapeutic Innovation & Regulatory Science|October 6, 2020
Characteristics of Industry-Sponsored Drug Clinical Trials Registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010-2018Eriko Kobayashi, Midori Matsuyama, Katsue Suzuki, et al.
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