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Therapeutic Innovation & Regulatory Science|May 2, 2018
Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical TrialsRichard C Zink, Olga Marchenko, Matilde Sanchez-Kam, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016Hideyuki Kondo, Agnès Saint-Raymond, Naoyuki YasudaTherapeutic Innovation & Regulatory Science|May 2, 2018
Design of Brand Names of Medicines Considering Subjects' PreferencesCarla Maria Batista Ferreira Pires, Afonso CavacoTherapeutic Innovation & Regulatory Science|May 2, 2018
Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for SarcomaAkihiro Hirakawa, Tadaaki Nishikawa, Kan Yonemori, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report DatabaseYomei Matsuoka, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|May 2, 2018
A Resource-Based Relative Value for Clinical Research Nurses' WorkloadSangmi Lee, Ihn Sook JeongTherapeutic Innovation & Regulatory Science|May 2, 2018
A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical TrialsTakuma Matsuda, Hiroyo Karube, Atsushi ArugaTherapeutic Innovation & Regulatory Science|May 2, 2018
Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in JapanShoyo Shibata, Maiko Matsushita, Yoshimasa Saito, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research OrganizationsMary Jo Lamberti, Michael Wilkinson, Beth Harper, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based MonitoringRichard C Zink, Anastasia Dmitrienko, Alex DmitrienkoPageof 165