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

Author:

Shimomura Akihiko,Kondo Shunsuke,Kobayashi Noriko,Iwasa Satoru,Kitano Shigehisa,Tamura Kenji,Fujiwara Yutaka,Yamamoto Noboru

Publisher

Springer Science and Business Media LLC

Subject

Oncology,Hematology,General Medicine,Surgery

Reference11 articles.

1. ICH safety guidelines. http://www.ich.org/products/guidelines.html

2. (2005) Guideline for clinical evaluation of anti-cancer drugs. In: Ministry of Health and Welfare

3. Hyman DM, Eaton AA, Gounder MM et al (2014) Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials. J Clin Oncol 32(6):519–526

4. Postel-Vinay S, Gomez-Roca C, Molife LR et al (2011) Phase I trials of molecularly targeted agents: should we pay more attention to late toxicities? J Clin Oncol 29(13):1728–1735

5. Common terminology criteria for adverse events version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE/About.html

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