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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 no: | Int J Clin Oncol |
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Main Authors: | , , , , , , , |
Formato: | Artigo |
Idioma: | Inglês |
Publicado em: |
Springer Japan
2017
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Assuntos: | |
Acesso em linha: | 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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