title: [The revision of Guidelines for Clinical Evaluation Methods of Anti-Cancer Drugs in Japan].
abstract: It has been ten years since the Ministry of Health and Welfare in Japan issued Guidelines for Clinical Evaluation Methods of anti-cancer Drugs in February, 1991. The circumstance surrounding anti-cancer drugs have now changed dramatically with the development of molecular-targeting drugs, introduction of clinical data in overseas countries for approval of new drugs in Japan, etc. Based on these changes, this guideline was revised in November 2005.
authors.affiliation: Division of Breast and Oncology, National Cancer Center Hospital.
authors.forename: Masashi
authors.initials: M
authors.lastname: Andoh
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D005069:Evaluation Studies as Topic; D006801:Humans; D007564:Japan; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic
chemical_list: D000970:Antineoplastic Agents