[Phase II study].
It is 4 years since the Ministry of Health and Welfare of Japan introduced "The Guidelines on Clinical Evaluation for Anti-tumor Drugs" in February 1991. From the stand point that I have conducted several clinical studies on new anti-tumor drugs according to the Guidelines, this review pointed out some practical problems in the process to develop Phase II study based on the Guidelines.
Niitani
H
H
Headquarters of Foundation, Nippon Medical School, Tokyo, Japan.
D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077143:Docetaxel; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000031:analogs & derivatives / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D043823:Taxoids; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine