Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan

INTRODUCTION: Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. PATIENTS AND METHOD...

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Publicado en:Int J Clin Oncol
Autores principales: Shimomura, Akihiko, Kondo, Shunsuke, Kobayashi, Noriko, Iwasa, Satoru, Kitano, Shigehisa, Tamura, Kenji, Fujiwara, Yutaka, Yamamoto, Noboru
Formato: Artigo
Lenguaje:Inglês
Publicado: Springer Japan 2017
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Original Article
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC5533862/
https://ncbi.nlm.nih.gov/pubmed/28293794
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s10147-017-1108-z
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