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Pharmaceutical Medicine|January 15, 2020
Evaluation of the Implementation of Additional Risk Minimization Activities in Europe, the USA, and JapanYuka Yasuoka, Masayuki Kaneko, Mamoru Narukawa
Journal of Clinical Pharmacy and Therapeutics|December 18, 2019
Post-marketing safety-related regulatory actions on first-in-class drugs: A double-cohort studyJunji Ikeda, Masayuki Kaneko, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|September 1, 2020
Pediatric Drug Development in Japan: A Comparison of the Current Situation and Characteristics Between Japan and EuropeEiji Ueyama, Masayuki Kaneko, Mamoru Narukawa
Clinical Pharmacology and Therapeutics|June 9, 2018
A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor CancersKenji Yamashita, Masayuki Kaneko, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|July 1, 2020
Factors Related to Conversion from Accelerated to Full Approval for Drugs Approved in the United States Between 2000 and 2016Koji Irisawa, Masayuki Kaneko, Mamoru Narukawa
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