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Therapeutic Innovation & Regulatory Science|September 18, 2018
Comparison of Approved Dosages for Pediatric and Adult Populations Based on US Labeling InformationKeizo Hanada, Masayuki Kaneko, Mamoru Narukawa
European Journal of Clinical Pharmacology|May 27, 2019
Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancerKenji Yamashita, Masayuki Kaneko, Mamoru Narukawa
Journal of Oncology Practice|November 15, 2017
Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology ProductsAtsushi Hyogo, Masayuki Kaneko, Mamoru Narukawa
International Journal of Clinical Oncology|October 15, 2020
Comparison of efficacy outcomes of anticancer drugs between Japanese patients and the overall populationToshiyuki Tamai, Masayuki Kaneko, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|September 22, 2020
Analysis of Pediatric Drug Approval Lag in JapanEiji Ueyama, Masayuki Kaneko, Mamoru Narukawa
Clinical Pharmacology in Drug Development|April 29, 2016
Impact of Clinical Response on Different Approved Doses in Japan and the United StatesYuko Sugita, Eisuke Inoue, Mamoru Narukawa
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