Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs

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作者
Kojiro Maeda
Masayuki Kaneko
Mamoru Narukawa
Teruyo Arato
机构
[1] Hokkaido University Graduate School of Medicine,Department of Regulatory Science
[2] Kitasato University,Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Science
[3] Hokkaido University Hospital Clinic Research and Medical Innovation Center,undefined
关键词
Ultra-orphan drugs; Review reports; Clinical trials; Guidance;
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